District Business Manager jobs at Novo Nordisk - 25 jobs

About the Department Our Marketing & Patient Solutions group creates and delivers human-centered experiences, where innovation meets customer-centricity, driving the ultimate experience for our patients. Our focus extends beyond transactions to craft experiences as one fully integrated, aligned and connected organization that puts empathy at the center, powered by insight and foresight. We develop an end-to-end approach to strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our strategies are rooted in a deep understanding of customer needs and behaviors. Our 'test and learn' mindset and approach enables us to iterate rapidly and refine our strategies based on real-world results. We are building an intentional team culture that is made up of diverse skillsets, united by the shared belief that reinvention and learning is what fuels continuous growth. Do you get excited about exploring the unknown? Does the idea of driving value through human-centered design pull you in? Are you ready to experiment with us? **This is not a remote opportunity. Must be available to come in the office 5 days a week. The Position The Senior Manager, Enterprise Insights, provides insights primary market research to help guide Novo Nordisk on portfolio, franchise, and brand strategy development and execution. The role supports specific brands and therapy areas, and provides holistic, insight-driven consultation and evidence-based strategic and tactical guidance to all levels of marketing stakeholders. In addition to Marketing, this role partners with other stakeholders and Enterprise Insights teams to ensure proper alignment and impact on Novo Nordisk's business. Relationships Reports to a Director or Senior Director in Enterprise Insights and will act on behalf of this role in certain situations. Has frequent interaction with - and may indirectly manage on a day-to-day basis - the work of one or more NN Global Business Services offshore team colleagues. Interact directly and frequently with stakeholders in Marketing and owns the relationship with these on behalf of Enterprise Insights. Also interacts with other stakeholders across the NN organization. In addition to internal relationships mentioned above, external relationships include interactions with professional services and consultants. Essential Functions Design and execute primary market research to uncover opportunities and mitigate risks associated with the core strategic priorities of the Brand Identify business challenge or opportunity in direct collaboration with key stakeholders. Scope, plan and execute analyses to answer business question. Build a story and presentation with recommendations on how address the challenge or opportunity. Create holistic views of the market situations and the opportunities and challenges for our business, through analyses utilizing our various data set and market research studies. Guide the brand teams and other stakeholder in their strategic and tactical decisions, through recommendations in presentations, meetings, and workshops. Drive and manage projects and initiatives to create greater impact of our sales and marketing effort. Physical Requirements Approximately 0-5% overnight travel. Qualifications Bachelor's degree required. MBA, M.Sc., or other advanced degree preferred. 6 years of relevant work experience preferred Strong analytical, quantitative, and qualitative analysis skills required Strong Microsoft Office skills - especially Excel and PowerPoint required. Experience with Tableau preferred Primary Market Research experience preferred Experience working with IQVIA data preferred Creative problem solving; ability to organize/manipulate data and see big picture from scattered pieces of information Strong writing, presentation, project management skills required Demonstrated ability to managed multiple projects with conflicting deadlines Positive and eagerness to learn, collaborate and partner with internal business colleagues We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger - a legacy of impact that reaches far beyond today. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at **************. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Job title: Area Business Manager, Dermatology, South New Jersey About the Job Sanofi focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families. Sanofi has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases, oncology, immunology, and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Sanofi's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. At Sanofi, we are committed to the growth of our people, connected in purpose by career, life and health. The Area Business Manager (ABM) is responsible for engaging Dermatologists and other key customers within an assigned geography and presenting clinically focused selling messages to create and grow revenue and to consistently deliver product goals related to Atopic Dermatitis, Prurigo Nodularis, CSU and BP. The ABM will demonstrate initiative, drive, independence, and take ownership for meeting and exceeding individual business goals. This will be accomplished by driving performance and delivering results in a compliant manner with a high degree of integrity strictly following all Sanofi US policies and in compliance with all policies and procedures governing the promotion of pharmaceutical/biological products in the US. We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological conditions. In Specialty Care, you'll help deliver breakthrough treatments that bring hope to patients with some of the highest unmet needs. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities Engage Dermatology/Immunology customers within assigned geographical territory and deliver clinically focused message to introduce, launch, grow brand-share and revenue and to consistently deliver on product goals for atopic dermatitis and other dermatological indications. Collaborate and coordinate with other key field-based stakeholders such as Regeneron Sales Professional counterparts, Medical Science Liaisons, Field Reimbursement and Market Access teammates, Thought Leader Liaisons, and others in their territory to proactively address customer needs, identify market dynamics and trends, develop strategies which support brand and corporate objectives, and ensure optimal account success within their assigned geography. Develop strong working relationships with Dermatology experts in assigned geography as well as biologic coordinators, office staff and other important health care personnel and key patient advocacy support groups as directed. Drive results by identifying key opportunities and developing strategic business plans to generate product utilization and grow territory business. Plan, organize, and execute local promotional speaker programs and activities. Maximize budget allocated to the geographic territory to support execution of strategies and tactics and generate/grow the business. Participate and help lead initiatives to support sales success as assigned (e.g. participate in industry related congresses, local and regional meetings and medical conferences). Own business opportunities within respective geographic area, which includes coordination and calling upon large group practices and other key targets to drive overall product results. Establish relationship with thought leaders in assigned territory. Primary objective is to drive industry leading customer value. About You Basic Qualifications: Bachelor's degree from an accredited four-year college or university. 3+ years of pharmaceutical, biotech, or medical device sales experience. Demonstrated ability to learn and apply technical and scientific product-related information. Ability to travel to meetings/trainings/programs as necessary - additional travel may be required within the assigned territory. Proven success and positive track record of consistent sales performance in complex markets with diverse customer segments operating with a high degree of integrity within compliance guidelines. Ability to operate as a “team player” in cooperation with collaboration partners and internal colleagues to reach common goals. Valid Driver's License. Preferred Qualifications: 2+ years selling sub-cutaneous self-injectable (or office administered IV) biologics in a complex and competitive market. 2+ years selling experience in dermatologic disorders such as atopic dermatitis strongly preferred. 2+ years selling experience calling on Dermatologists. Launch experience in specialty care and biologics strongly preferred. Alliance/matrix partnership experience strongly preferred. Demonstrate advanced clinically based selling skills. Results oriented with a proven track record of success with product launches. Experience with in-servicing and training office staff, nurses and office managers. Demonstrate a passion and learning aptitude for science and is proactive in strengthening knowledge related to disease-state, treatment options and healthcare trends. Highly organized with strong account management skills. Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents. This position is eligible for a company car through the Company's FLEET program. Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Remote #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $125,250.00 - $180,916.66 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.

**Job Title:** _Area Business Manager, Dermatology, Wayne, NJ_ **About the Job** Sanofi focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families. Sanofi has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases, oncology, immunology and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Sanofi's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. At Sanofi, we are committed to the growth of our people, connected in purpose by career, life and health. The Area Business Manager (ABM) is responsible for engaging Dermatologists and other key customers within an assigned geography and presenting clinically focused selling messages to create and grow revenue and to consistently deliver product goals related to Atopic Dermatitis, Prurigo Nodularis, Chronic Spontaneous Urticaria, Bullous Pemphigoid. The ABM will demonstrate initiative, drive, independence, and take ownership for meeting and exceeding individual business goals. This will be accomplished by driving performance and delivering results in a compliant manner with a high degree of integrity strictly following all Sanofi US policies and in compliance with all policies and procedures governing the promotion of pharmaceutical/biological products in the US. We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological conditions. In Specialty Care, you'll help deliver breakthrough treatments that bring hope to patients with some of the highest unmet needs. **About Sanofi** : We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. **Main Responsibilities** + Engage Dermatology/Immunology customers within assigned geographical territory and deliver clinically focused message to introduce, launch, grow brand-share and revenue and to consistently deliver on product goals for atopic dermatitis and other dermatological indications. + Collaborate and coordinate with other key field-based stakeholders such as Regeneron Sales Professional counterparts, Medical Science Liaisons, Field Reimbursement and Market Access teammates, Thought Leader Liaisons, and others in their territory to proactively address customer needs, identify market dynamics and trends, develop strategies which support brand and corporate objectives, and ensure optimal account success within their assigned geography. + Develop strong working relationships with Dermatology experts in assigned geography as well as biologic coordinators, office staff and other important health care personnel and key patient advocacy support groups as directed. + Drive results by identifying key opportunities and developing strategic business plans to generate product utilization and grow territory business. + Plan, organize, and execute local promotional speaker programs and activities. + Maximize budget allocated to the geographic territory to support execution of strategies and tactics and generate/grow the business. + Participate and help lead initiatives to support sales success as assigned (e.g. participate in industry related congresses, local and regional meetings and medical conferences) + Own business opportunities within respective geographic area, which includes coordination and calling upon large group practices and other key targets to drive overall product results. + Establish relationship with thought leaders in assigned territory. Primary objective is to drive industry leading customer value. **About You:** **Basic Qualifications:** + Bachelor's degree from an accredited four-year college or university. + 3+ years of pharmaceutical, biotech, or medical device sales experience. + Demonstrated ability to learn and apply technical and scientific product-related information. + Ability to travel to meetings/trainings/programs as necessary - additional travel may be required within the assigned territory. + Proven success and positive track record of consistent sales performance in complex markets with diverse customer segments operating with a high degree of integrity within compliance guidelines. + Ability to operate as a "team player" in cooperation with collaboration partners and internal colleagues to reach common goals. + Valid Driver's License. **Preferred Qualifications:** + 2+ years selling sub-cutaneous self-injectable (or office administered IV) biologics in a complex and competitive market. + 2+ years selling experience in dermatologic disorders such as atopic dermatitis strongly preferred. + 2+ years selling experience calling on Dermatologists. + Launch experience in specialty care and biologics strongly preferred. + Alliance/matrix partnership experience strongly preferred. + Demonstrate advanced clinically based selling skills. + Results oriented with a proven track record of success with product launches. + Experience with in-servicing and training office staff, nurses and office managers. + Demonstrate a passion and learning aptitude for science and is proactive in strengthening knowledge related to disease-state, treatment options and healthcare trends. + Highly organized with strong account management skills. + Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents. _This position is eligible for a company car through the Company's FLEET program. Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents._ **Why Choose Us?** + Bring the miracles of science to life alongside a supportive, future-focused team. + Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. + Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. + Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. \#GD-SG \#LI-GZ \#LI-Remote \#vhd **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. _North America Applicants Only_ The salary range for this position is: $125,250.00 - $180,916.66 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (********************************************************************************************************* . Global Terms & Conditions and Data Privacy Statement (*************************************************************** Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (***************************** As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************

**Job title:** _Area Business Manager, Dermatology, Wayne, NJ_ **About the Job** Sanofi focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families. Sanofi has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases, oncology, immunology, and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Sanofi's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. At Sanofi, we are committed to the growth of our people, connected in purpose by career, life and health. The Area Business Manager (ABM) is responsible for engaging Dermatologists and other key customers within an assigned geography and presenting clinically focused selling messages to create and grow revenue and to consistently deliver product goals related to Atopic Dermatitis, Prurigo Nodularis, CSU and BP. The ABM will demonstrate initiative, drive, independence, and take ownership for meeting and exceeding individual business goals. This will be accomplished by driving performance and delivering results in a compliant manner with a high degree of integrity strictly following all Sanofi US policies and in compliance with all policies and procedures governing the promotion of pharmaceutical/biological products in the US. We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological conditions. In Specialty Care, you'll help deliver breakthrough treatments that bring hope to patients with some of the highest unmet needs. **About Sanofi:** We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. **Main Responsibilities** + Engage Dermatology/Immunology customers within assigned geographical territory and deliver clinically focused message to introduce, launch, grow brand-share and revenue and to consistently deliver on product goals for atopic dermatitis and other dermatological indications. + Collaborate and coordinate with other key field-based stakeholders such as Regeneron Sales Professional counterparts, Medical Science Liaisons, Field Reimbursement and Market Access teammates, Thought Leader Liaisons, and others in their territory to proactively address customer needs, identify market dynamics and trends, develop strategies which support brand and corporate objectives, and ensure optimal account success within their assigned geography. + Develop strong working relationships with Dermatology experts in assigned geography as well as biologic coordinators, office staff and other important health care personnel and key patient advocacy support groups as directed. + Drive results by identifying key opportunities and developing strategic business plans to generate product utilization and grow territory business. + Plan, organize, and execute local promotional speaker programs and activities. + Maximize budget allocated to the geographic territory to support execution of strategies and tactics and generate/grow the business. + Participate and help lead initiatives to support sales success as assigned (e.g. participate in industry related congresses, local and regional meetings and medical conferences). + Own business opportunities within respective geographic area, which includes coordination and calling upon large group practices and other key targets to drive overall product results. + Establish relationship with thought leaders in assigned territory. Primary objective is to drive industry leading customer value. **About You** **Basic Qualifications:** + Bachelor's degree from an accredited four-year college or university. + 3+ years of pharmaceutical, biotech, or medical device sales experience. + Demonstrated ability to learn and apply technical and scientific product-related information. + Ability to travel to meetings/trainings/programs as necessary - additional travel may be required within the assigned territory. + Proven success and positive track record of consistent sales performance in complex markets with diverse customer segments operating with a high degree of integrity within compliance guidelines. + Ability to operate as a "team player" in cooperation with collaboration partners and internal colleagues to reach common goals. + Valid Driver's License. **Preferred Qualifications:** + 2+ years selling sub-cutaneous self-injectable (or office administered IV) biologics in a complex and competitive market. + 2+ years selling experience in dermatologic disorders such as atopic dermatitis strongly preferred. + 2+ years selling experience calling on Dermatologists. + Launch experience in specialty care and biologics strongly preferred. + Alliance/matrix partnership experience strongly preferred. + Demonstrate advanced clinically based selling skills. + Results oriented with a proven track record of success with product launches. + Experience with in-servicing and training office staff, nurses and office managers. + Demonstrate a passion and learning aptitude for science and is proactive in strengthening knowledge related to disease-state, treatment options and healthcare trends. + Highly organized with strong account management skills. + Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents. _This position is eligible for a company car through the Company's FLEET program. Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents._ **Why Choose Us?** + Bring the miracles of science to life alongside a supportive, future-focused team. + Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. + Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. + Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. \#GD-SG \#LI-GZ \#LI-Remote \#vhd **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. _North America Applicants Only_ The salary range for this position is: $125,250.00 - $180,916.66 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (********************************************************************************************************* . Global Terms & Conditions and Data Privacy Statement (*************************************************************** Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (***************************** As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************

Job title: Area Business Manager, Dermatology, Wayne, NJ About the Job Sanofi focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families. Sanofi has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases, oncology, immunology, and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Sanofi's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. At Sanofi, we are committed to the growth of our people, connected in purpose by career, life and health. The Area Business Manager (ABM) is responsible for engaging Dermatologists and other key customers within an assigned geography and presenting clinically focused selling messages to create and grow revenue and to consistently deliver product goals related to Atopic Dermatitis, Prurigo Nodularis, CSU and BP. The ABM will demonstrate initiative, drive, independence, and take ownership for meeting and exceeding individual business goals. This will be accomplished by driving performance and delivering results in a compliant manner with a high degree of integrity strictly following all Sanofi US policies and in compliance with all policies and procedures governing the promotion of pharmaceutical/biological products in the US. We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological conditions. In Specialty Care, you'll help deliver breakthrough treatments that bring hope to patients with some of the highest unmet needs. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities Engage Dermatology/Immunology customers within assigned geographical territory and deliver clinically focused message to introduce, launch, grow brand-share and revenue and to consistently deliver on product goals for atopic dermatitis and other dermatological indications. Collaborate and coordinate with other key field-based stakeholders such as Regeneron Sales Professional counterparts, Medical Science Liaisons, Field Reimbursement and Market Access teammates, Thought Leader Liaisons, and others in their territory to proactively address customer needs, identify market dynamics and trends, develop strategies which support brand and corporate objectives, and ensure optimal account success within their assigned geography. Develop strong working relationships with Dermatology experts in assigned geography as well as biologic coordinators, office staff and other important health care personnel and key patient advocacy support groups as directed. Drive results by identifying key opportunities and developing strategic business plans to generate product utilization and grow territory business. Plan, organize, and execute local promotional speaker programs and activities. Maximize budget allocated to the geographic territory to support execution of strategies and tactics and generate/grow the business. Participate and help lead initiatives to support sales success as assigned (e.g. participate in industry related congresses, local and regional meetings and medical conferences). Own business opportunities within respective geographic area, which includes coordination and calling upon large group practices and other key targets to drive overall product results. Establish relationship with thought leaders in assigned territory. Primary objective is to drive industry leading customer value. About You Basic Qualifications: Bachelor's degree from an accredited four-year college or university. 3+ years of pharmaceutical, biotech, or medical device sales experience. Demonstrated ability to learn and apply technical and scientific product-related information. Ability to travel to meetings/trainings/programs as necessary - additional travel may be required within the assigned territory. Proven success and positive track record of consistent sales performance in complex markets with diverse customer segments operating with a high degree of integrity within compliance guidelines. Ability to operate as a “team player” in cooperation with collaboration partners and internal colleagues to reach common goals. Valid Driver's License. Preferred Qualifications: 2+ years selling sub-cutaneous self-injectable (or office administered IV) biologics in a complex and competitive market. 2+ years selling experience in dermatologic disorders such as atopic dermatitis strongly preferred. 2+ years selling experience calling on Dermatologists. Launch experience in specialty care and biologics strongly preferred. Alliance/matrix partnership experience strongly preferred. Demonstrate advanced clinically based selling skills. Results oriented with a proven track record of success with product launches. Experience with in-servicing and training office staff, nurses and office managers. Demonstrate a passion and learning aptitude for science and is proactive in strengthening knowledge related to disease-state, treatment options and healthcare trends. Highly organized with strong account management skills. Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents. This position is eligible for a company car through the Company's FLEET program. Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Remote #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $125,250.00 - $180,916.66 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.

**Job title:** Senior Manager of Digital Alliances **About the job:** This position supports a portfolio of digital alliances, ensuring coordination and value creation across functional experts, operational units within Sanofi, and alliance partners. You will oversee partnerships to ensure they remain on track to deliver impact consistent with strategic priorities and contractual obligations. Additionally, you'll support the Senior Director and DSP team in negotiating new deals and amending existing agreements, bringing valuable lessons from current partnerships into future collaborations. The role demands strong stakeholder management and leadership skills, along with a self-starter mentality. You must be able to identify business needs across various functions within Sanofi and work effectively in an ambiguous environment. Success requires sharp business acumen, the ability to forge productive partnerships, and the capability to drive cross-functional and cross-national teams toward results without direct reporting lines. The Digital Strategic Partnerships team operates within Sanofi Digital's Digital Innovation & Partnerships organization, a global enabling function focused on digital growth and transformation. The team's mission is to seek, execute, and establish partner relationships that address Sanofi's digital strategic priorities. This includes search and assessment, evaluation, structuring, negotiation, closing, and management of strategic alliances with external companies involving digital products, technologies, and assets. Sanofi believes digital innovation will transform how therapies are discovered, developed, and delivered to patients, providers, and payers. Digital solutions offer new opportunities to improve care, reduce costs, and enhance patient and consumer experiences. Partnering with digital health startups, tech companies, and other innovators is critical to driving this transformation. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. Digital & Data is at the heart of Sanofi: our ambition is to be the leading digital healthcare platform to develop & deliver medicine faster, enable healthcare professionals to improve treatments and help patients improve their health. Ready to get started? **Main responsibilities:** + Manage assigned alliances and provide regular updates to internal stakeholders on alliance health, focusing on strategic and contractual aspects of relationships. + Monitor and oversee collaborative projects, delivering quarterly updates that track progress, timelines, and performance metrics to ensure successful execution. + Facilitate effective communication between internal teams and alliance partners to ensure adequate information flow and knowledge transfer. + Maintain accurate records of alliance activities and agreements, ensuring information is updated in appropriate internal systems. + Assess and mitigate risks associated with assigned alliances while ensuring compliance with legal and regulatory requirements. + Manage alliance governance to ensure internal alignment of Sanofi committee members and effective decision-making of governance bodies. + Ensure committee meetings are conducted efficiently and regularly, driving key meeting components including objectives, agendas, and minutes. + Identify changes and make adjustments or recommendations to governance structures as needed to optimize alliance effectiveness. + Ensure compliance with contractual provisions and rights in collaboration with Legal, Commercial Operations, Digital, IA, and R&D teams. + Recommend necessary contract amendments and participate in renegotiation processes in close collaboration with Legal, Partnering, and other functions. + Anticipate and manage disagreements and disputes, minimize conflict, and avoid breach of contract and litigation risks. + Establish and build a Digital Alliances Center of Excellence (COE) with the Senior Director of Alliances, capturing digital alliance best practices and creating a community within Sanofi for sharing and exchanging ideas. + Participate in strategic research projects with Senior Director of Alliances and Partnership colleagues, including benchmarking Sanofi Digital Alliances against competitors within and outside the industry. + Contribute to Digital Strategic Partnerships & Alliances cross-team projects as required **About you:** + Minimum of 4+ years of work experience in life sciences/health care or tech industry. + Master's degree in Sciences or Business-related field is required. An MBA and/or an advanced Scientific/Engineering degree (e.g., PharmD or PhD) is a plus. + Advanced knowledge of MS Office applications + Ability to organize, collaborate and lead cross-functionally with scientific, engineering, digital, data, finance, and/or commercial team members. + Proven soft skills: ability to listen, interpret and respond to information that may be sensitive and material for both Sanofi and the alliance Partner. + Experience in interacting in a highly professional manner with senior executives both within the parent organization and with partner companies. + Knowledge of the pharmaceutical/biotech/medical device/technology industry(ies). + Knowledge of new digital technologies, terminology, tech / start-up culture, product development processes (e.g. agile) + Highly motivated and team-oriented professional eager to face business challenges, share experiences and add sustainable value to the organization. **Why choose us?** + We provide a highly collaborative environment, with an opportunity to work with a world class team. + Contribute to a company that is not only a leader in healthcare but also a pioneer in digital transformation, shaping the future of global health. + Bring the miracles of science to life alongside a supportive, future-focused team. + Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. + Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. + Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. \#GD-SA \#LI-SA \#LI-Onsite \#VHD **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. _North America Applicants Only_ The salary range for this position is: $147.000,00 - $212.333,33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (********************************************************************************************************* . Global Terms & Conditions and Data Privacy Statement (*************************************************************** Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (***************************** As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************

Job title: Senior Manager of Digital Alliances About the job: This position supports a portfolio of digital alliances, ensuring coordination and value creation across functional experts, operational units within Sanofi, and alliance partners. You will oversee partnerships to ensure they remain on track to deliver impact consistent with strategic priorities and contractual obligations. Additionally, you'll support the Senior Director and DSP team in negotiating new deals and amending existing agreements, bringing valuable lessons from current partnerships into future collaborations. The role demands strong stakeholder management and leadership skills, along with a self-starter mentality. You must be able to identify business needs across various functions within Sanofi and work effectively in an ambiguous environment. Success requires sharp business acumen, the ability to forge productive partnerships, and the capability to drive cross-functional and cross-national teams toward results without direct reporting lines. The Digital Strategic Partnerships team operates within Sanofi Digital's Digital Innovation & Partnerships organization, a global enabling function focused on digital growth and transformation. The team's mission is to seek, execute, and establish partner relationships that address Sanofi's digital strategic priorities. This includes search and assessment, evaluation, structuring, negotiation, closing, and management of strategic alliances with external companies involving digital products, technologies, and assets. Sanofi believes digital innovation will transform how therapies are discovered, developed, and delivered to patients, providers, and payers. Digital solutions offer new opportunities to improve care, reduce costs, and enhance patient and consumer experiences. Partnering with digital health startups, tech companies, and other innovators is critical to driving this transformation. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. Digital & Data is at the heart of Sanofi: our ambition is to be the leading digital healthcare platform to develop & deliver medicine faster, enable healthcare professionals to improve treatments and help patients improve their health. Ready to get started? Main responsibilities: * Manage assigned alliances and provide regular updates to internal stakeholders on alliance health, focusing on strategic and contractual aspects of relationships. * Monitor and oversee collaborative projects, delivering quarterly updates that track progress, timelines, and performance metrics to ensure successful execution. * Facilitate effective communication between internal teams and alliance partners to ensure adequate information flow and knowledge transfer. * Maintain accurate records of alliance activities and agreements, ensuring information is updated in appropriate internal systems. * Assess and mitigate risks associated with assigned alliances while ensuring compliance with legal and regulatory requirements. * Manage alliance governance to ensure internal alignment of Sanofi committee members and effective decision-making of governance bodies. * Ensure committee meetings are conducted efficiently and regularly, driving key meeting components including objectives, agendas, and minutes. * Identify changes and make adjustments or recommendations to governance structures as needed to optimize alliance effectiveness. * Ensure compliance with contractual provisions and rights in collaboration with Legal, Commercial Operations, Digital, IA, and R&D teams. * Recommend necessary contract amendments and participate in renegotiation processes in close collaboration with Legal, Partnering, and other functions. * Anticipate and manage disagreements and disputes, minimize conflict, and avoid breach of contract and litigation risks. * Establish and build a Digital Alliances Center of Excellence (COE) with the Senior Director of Alliances, capturing digital alliance best practices and creating a community within Sanofi for sharing and exchanging ideas. * Participate in strategic research projects with Senior Director of Alliances and Partnership colleagues, including benchmarking Sanofi Digital Alliances against competitors within and outside the industry. * Contribute to Digital Strategic Partnerships & Alliances cross-team projects as required About you: * Minimum of 4+ years of work experience in life sciences/health care or tech industry. * Master's degree in Sciences or Business-related field is required. An MBA and/or an advanced Scientific/Engineering degree (e.g., PharmD or PhD) is a plus. * Advanced knowledge of MS Office applications * Ability to organize, collaborate and lead cross-functionally with scientific, engineering, digital, data, finance, and/or commercial team members. * Proven soft skills: ability to listen, interpret and respond to information that may be sensitive and material for both Sanofi and the alliance Partner. * Experience in interacting in a highly professional manner with senior executives both within the parent organization and with partner companies. * Knowledge of the pharmaceutical/biotech/medical device/technology industry(ies). * Knowledge of new digital technologies, terminology, tech / start-up culture, product development processes (e.g. agile) * Highly motivated and team-oriented professional eager to face business challenges, share experiences and add sustainable value to the organization. Why choose us? * We provide a highly collaborative environment, with an opportunity to work with a world class team. * Contribute to a company that is not only a leader in healthcare but also a pioneer in digital transformation, shaping the future of global health. * Bring the miracles of science to life alongside a supportive, future-focused team. * Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. * Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. * Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA #LI-Onsite #VHD Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $147.000,00 - $212.333,33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.

The Senior Manager, Global Pharmacovigilance (GPV) Compliance & Business Management (CBM), will support in the development and implementation of necessary processes for the management of routine compliance activities within the pharmacovigilance organization. This is a global role. The job holder will also work collaboratively with other GPV groups, Affiliate PV Coordination Group (APVC), Global Quality Operations (GQO), the Global QPPV office and Regional Pharmacovigilance Heads to identify and meet various Global CBM objectives. _*At the discretion of the Global Head of CBM, it may be required to support activities within multi sub-function project teams as needed._ **Key Responsibilities:** **GPV Alliance Management (GPVAM)** + Responsible for supporting the development and maintenance of Pharmacovigilance Agreements (PVAs) + Responsible for ensuring compliance with global, local and regional PV regulations and policies/procedures and take corrective and/or preventive actions, when needed and as applicable to PVAs + Support PV audits/inspections and assist in developing CAPAs in response to findings/observations in relation to PVAs and compliance + Manage routine compliance metrics in pharmacovigilance activities related to PVAs + Perform impact analysis regarding PV compliance strategies and work instructions including input into PVAs + Participate in the root cause analysis, identification and investigation of non-adherence (deviations) to PV requirements in accordance with the PVA or PVA processes. + Facilitate round table reviews/comments resolution meetings as needed + Support other GPVAM activities as applicable. **GPV Compliance & Analytics** + Responsible for compiling compliance metrics according to local and regional PV regulations and Otsuka's policies/procedures and to request implementation of corrective and/or preventive actions, when needed + Ensure implementation of relevant updates to PV regulations to the impacted tasks in scope of the role, within the required timeline. + Develop and implement metrics and dashboards to ensure regulatory requirements for PV are compiled and risks are minimized. + Facilitate early detection of potential compliance through trend analyses and subsequent timely reporting to the relevant regional stakeholders (e.g. in Europe the EU-QPPV has to be included) + Responsible for driving automation and innovation in compliance monitoring **Additional activities:** + Attend Global / Regional meetings as required + Present compliance metrics at Global Meetings + Contribute to maintenance of PV System Master File as required. + May be assigned to lead or assist with special projects or process development. + May perform any other duties as needed. **Job Scope (key facts & figures)** + Travel as applicable + Knowledge of ICH, US & EU regulations and requirements for pharmacovigilance + Solid background and experience in pharmaceutical quality system management (GxP) + Experience with participation in PV audits in the pharmaceutical industry + Strong project management, interpersonal, communication and presentation skills + Ability to accomplish objectives through influence in a matrix organization + Strong computer skills with Word, Excel, PowerPoint, and Outlook **Qualifications/ Experience Required** + Bachelor's degree + Expertise in Good Pharmacovigilance Practice (GPvP) + Technical skills & experience + Minimum 2 years PV Compliance or Quality Management experience in the pharmaceutical industry + Microsoft proficient **Competencies Required** + Excellent written and verbal communication with internal and external customers + Excellent planning and organizational skills + Strong collaboration and self-leadership skills + Adapt business acumen in decision making + Ability to work autonomously, take accountability for actions **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $134,615.00 - Maximum $201,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary The Senior Manager, EHSS Performance Enablement supports the execution of EHSS performance monitoring, ensuring that EHSS systems and processes deliver accurate, reliable data for decision-making and lay the foundation for future predictive analytics capabilities. The role supports the maintenance and operational improvement of EHSS data and reporting systems, including performance measurement frameworks, maintaining data quality, and enabling analytics and visualization though data science to track EHSS performance. This role executes daily performance enablement activities, ensuring data accuracy and reliable reporting. The Senior Manager delivers on core EHSS analytics initiatives to meet departmental goals and operational objectives, partnering with internal stakeholders to optimize EHSS processes and leverage automation or AI solutions to reduce administrative workload and improve efficiency. Key Responsibilities Oversee the development, implementation and ongoing operational support for departmental EHSS dashboards, ensuring data quality and timely updates, including integration of forward looking EHSS performance metrics. Support configuration and maintenance of EHSS systems to ensure accurate data capture for incidents, risks, and other performance metrics. Identify and implement opportunities to apply AI and automation to EHSS processes, reducing administrative burden and enhancing operational efficiency. Collaborate with cross-functional teams to identify data-driven opportunities for risk reduction and process optimization. Contribute to the development of predictive analytics capabilities and unified performance measurement frameworks, through application of data science concepts. Partner with BI&T and other stakeholders to integrate advanced analytics and digital tools into EHSS workflows. Stay current on trends in data science and digital innovation, translating emerging technologies into practical EHSS applications. Provide training and guidance to EHSS stakeholders on performance reporting tools and processes. Resolve moderately complex issues related to data capture, reporting, and analytics by adapting existing processes or procedures. Provide technical guidance and training within the department/group on the use of EHSS reporting and data visualization tools. Contribute to systems implementation or digital process improvement projects as required. Collaborate with peers and internal customers to deliver project objectives and address resource/operational constraints. Coordinate with vendors to ensure routine flow of system activities and support issue resolution. Recommend improvements for departmental operational efficiency based on data analysis and established solutions. Qualifications & Experience Bachelor's degree in engineering, life sciences, information systems, or a related field. 5+ years of operational or project management experience in EHSS, analytics, or related field Strong understanding of EHSS performance measurement principles and data governance. Experience with dashboard development and data visualization tools (e.g., Power BI, Tableau). Background in AI-driven process improvement and digital tool implementation. Competency in applying existing digital tools to support operational needs Familiarity with current trends in data science, AI, and digital transformation. Strong communication and stakeholder engagement skills. #EHS_Opportunity #LI-Hybrid If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Devens - MA - US: $139,260 - $168,745 New Brunswick - NJ - US: $126,600 - $153,408 Princeton - NJ - US: $126,600 - $153,408 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit ************************************* Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients' lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at ***************************************** Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at ********************. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1598444 : Senior Manager, EHSS Performance Enablement

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Functional Area Description Clinical Data Management key focus is to ensure data quality, integrity & completeness of all data types (eCRF and non eCRF) collected in BMS clinical trials from study start to database lock. Position Summary The Senior Manager, Clinical Data Management is a leadership role considered essential to the sustainability and success of the BMS R&D pipeline. This role may report into Director, Clinical Data Management or Associate Director, Clinical Data Management This is an office-based in BMS New Jersey locations. Position Responsibilities Responsibilities will include, but are not limited to: Project Management and Leadership Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects Responsible for end-to-end clinical data management activities and serves as a primary point of contact for internal and external study team members Provides strong quality and project oversight over third party vendor responsible for data management deliverables Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway). Enforces data standard conventions and quality expectations for clinical data per defined processes Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization Chairs Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality and completeness Represents DM on cross-functional project teams & submission Teams Lead or support the Health Authority inspections and audits Provides coaching and quality oversight of junior Data Management Leads FSP/CRO/Vendor Oversight May act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA) Continuous improvement initiatives Provides the relevant support and input to continuous improvement activities within clinical data management Provides support for CAPA implementation as required Degree/ Experience Requirements Bachelor's Degree required with an advanced degree preferred At least 5 years of relevant industry experience. Project management certification (e.g. PMP) is desirable. Key Competency Requirements Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection Strong project management; Exhibits expertise in metrics analysis and reporting methodologies Excellent oral and written communication skills. Communicate effectively with senior management and cross-functional teams Knowledge of submission requirements, [e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)] Travel Required: 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed) If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Madison - Giralda - NJ - US: $143,590 - $173,998 Princeton - NJ - US: $143,590 - $173,998 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit ************************************* Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients' lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at ***************************************** Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at ********************. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1595778 : Senior Manager, Clinical Data Management

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position: Sr. Manager, ServiceNowLocation: Princeton, NJLocation: Tampa, FL At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Position Summary This position plays a key role in designing and maintaining ServiceNow. The person in this role will be responsible to deliver new technology features and support fixes to optimize BMS ServiceNow operations and functional enhancements. You will collaborate with stakeholders and IT teams to understand requirements and implement solutions that enrich the platform and enhance the user experience. At BMS, digital innovation and Information Technology are central to our vision of transforming patients' lives through science. To accelerate our ability to serve patients around the world, we must unleash the power of technology. We are committed to being at the forefront of transforming the way medicine is made and delivered by harnessing the power of computer and data science, artificial intelligence, and other technologies to promote scientific discovery, faster decision making, and enhanced patient care. If you want an exciting and rewarding career that is meaningful, consider joining our diverse team! Key Responsibilities Collaborate with stakeholders, system architects and IT teams to understand requirements and implement solutions that enrich the platform and enhance the user experience Design solution on ServiceNow platform through Workflow, Flow Designer, IntegrationHub, Orchestration, Mid Servers, Business Rules, Client Scripts, UI Actions, UI Policies, ACLs, SLAs, Registry Events, Scheduled Jobs etc. Support and identify opportunities for continuous improvement Adopt broad, enterprise-wide view and understanding of strategy, processes and capabilities Support business process re-engineering efforts for at least a couple medium-to-large software project Communicate status updates to stakeholders and manage expectations Conduct User Acceptance Testing (UAT) to ensure the requirements are met Engage and the support business services and ensure adherence to technology standards across capability delivery teams including service providers Work closely with cross-functional teams to deliver ServiceNow solutions Troubleshoot and resolve issues/incidents Collaborate with product managers and stakeholders to ensure requirements are clearly understood and backlog items are prioritized and partner with Developers to design and implement the solutions Demonstrate a flexible and adaptive approach to accommodate changing requirements. Must be self-directed with proven ability to make mature decisions supported by thorough data and process analysis. Qualifications & Experience Degree in Computer Science, Information Systems, related field, or equivalent work experience 6+ years of ServiceNow experience Broad exposure to ServiceNow modules (ITSM, ITAM, ITOM, IRM (GRC/TPRM), HRSD) Proficiency in ServiceNow platform capabilities including Service Catalog, Flow Designer, Workflow Editor, Scripting and Integration Hub etc. Strong analytical and problem-solving skills to troubleshoot and resolve technical issues Excellent communication and collaboration abilities to work effectively with cross-functional teams Ability to work independently, manage multiple priorities, and meet deadlines in a fast-paced environment Experience with ServiceNow integrations Experience with ServiceNow scripting languages Experience with ServiceNow reporting and analytics Experience with Agile development methodologies Experience with ServiceNow performance tuning and optimization Experience with ServiceNow security and compliance Experience with ServiceNow family and patching upgrades Makes decisions while understanding the team's work and how it fits into the broader enterprise Demonstrates awareness of functional business context and the impact on their own work Identifies opportunities to improve and grow, balancing performance feedback and career development Displays understanding of performance metrics driving the team's goals and questions the external environment and its' implication on the goals and strategies ServiceNow Certified System Administrator (CSA), Certified Application Developer (CAD) or Certified Implementation Specialist (CIS) certification is a plus Why You Should Apply Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Princeton - NJ - US: $139,570 - $169,126 Tampa - FL - US: $139,570 - $169,126 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit ************************************* Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients' lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at ***************************************** Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at ********************. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1598141 : Sr. Manager, ServiceNow Architecture & Administration

Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works collaboratively with members of the global regulatory team to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations. **J** **ob Responsibilities** - Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL). - Identifies the need and obtains regulatory intelligence, researches precedent approvals and prior health authority decisions to assess applicability to support development of strategic options for assigned Otsuka products. - Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs (as applicable) within company timelines and in accordance with regulations and guidelines. - Independently manages preparation of INDs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines. - Confirms submission documents are accurate, compliant, and high-quality to allow for smooth and expeditious approvals from regulatory authorities. - Serves as the sponsor point of contact to the health authority. - Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with GRL, to determine appropriate actions to meet timelines and/or resolve issues. - Effectively manages and directs internal support staff and external consultants for assigned projects. - Interacts effectively with internal/external functional business units to gather data and develop documentation required for on-time submissions. - Works closely with GRA department to execute departmental initiatives to improve overall efficiency, quality, and/or output. - Assess and develop innovative ideas to move GRA department to address current and future challenges. **K** **nowledge, Skills, and Competencies** **K** **nowledge** - Experience working in the pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC certification a plus. **Skills** - Strong oral and written communication skills. - Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc. - Able to successfully interpret and apply regulatory intelligence to work output. - Ability to lead teams, prioritized work, proactively manage and communicate issues, scopes progress and risks throughout the project lifecycle ensuring key stakeholders are informed. - Able to establish close communications and working relationship with cross functional teams to meet business objectives. Results-oriented, entrepreneurial, and self-motivated with excellent organizational skills with ability to learn and grow. - Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS). **Competencies** See OPDC Competencies Chart (Level X) **P** **hysical Demands and Work Environment** Travel (approximately 20%) See document Physical Demands and Work environment for further requirements. **Education and Related Experience** Bachelor's degree with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (e.g., clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Senior Manager, People Analytics is a critical analytical and technical expert within our HRIS & People Analytics team. This role supports the build-out and maturation of our People Analytics capability, delivering high-quality reporting, dashboards, insights, and data governance practices that empower business leaders to make informed workforce decisions. As a key member on the team, this individual plays a hands-on role in developing dashboards, conducting analytical deep-dives, managing data quality, and partnering with HR COEs, HR Business Partners, G&A functions, and the business. The role requires strong analytical rigor, excellent data storytelling skills, and comfort operating within a mid-sized, fast-paced pharmaceutical environment. **** + Provide data analytics to the business using either the tools available or implementing new tools that will provide managers with information that drive smart business decisions. + Responsible for maintaining or improving the systems and processes in place, to ensure strong data management practices and moving the department into a space where predictive analytics can support decision making. + Partner with HR, IT, Data Analytics and other internal colleagues and clients to solve problems using innovative methods to collect and analyze internal data, compare it to relevant industry data and identify insights and solutions. + Drive smarter business decisions by designing metrics, testing hypotheses, developing dashboards and delivery methods that will supply insights in both automated and targeted ways. + Adopt a consultative approach that develops and nurtures relationships with relevant internal/external stakeholders. + Manage the performance of Otsuka's HR technology vendors to ensure systems are maintained and integrated as necessary with each other and/or with other internal/external systems. + Identify system enhancements that will improve process or data capture and implement and execute on those initiatives. + Assist in developing and executing the People Analytics strategy (including reporting and analytics) for all our employee efforts. + Analyze and present data in a way that encourages a creative and collaborative approach to interpreting the information and helps proactively address business needs. + Design, build and automate key HR metrics, measurements and reports in collaboration with stakeholders and business leaders. + Support stakeholders and leaders to act based on predictive people analytics, insights identified, and recommendations made. + Develop rigorous analytical models that provide structure to ambiguous and complex issues. + Lead people analytics research projects including data collection and statistical analysis. + Create data audit reports and dashboards to ensure system data accuracy. + Support in development of knowledge and expertise of all People Analytics and Reporting services (e.g., KPIs, surveys, reports, dashboards, analytics) + Develop, conduct and administrate organization widesurveys and provide insights to internal leadership based on survey results data. **Qualifications/ Required** Knowledge/ Experience and Skills: + 5-8+ years of hands-on experience in People Analytics, HR analytics, data reporting, or HRIS. + Ability to convert complex data sets into digestible insights and stories. + Experience building HR dashboards and data models that support business decision-making. + Strong attention to detail and commitment to data accuracy. + Ability to work cross-functionally in a matrixed HR environment. + Strong leadership, interpersonal, and communication skills + Strong project management skills, ability to multitask by handling multiple projects and priorities simultaneously + Strong familiarity with survey platform (i.e. Qualtrics) + Fundamental process knowledge of HR processes and employee lifecycle management from recruitment to offboarding + Demonstrates strong problem-solving, analytical, negotiating, and decision-making skills + Demonstrates Learning Agility + Ability to effectively manage multiple resources including direct reports and external vendors + Ability to effectively interact with individuals at all levels of the organization + Ability to communicate effectively through presentations + Excellent computer skills including MS Office (Word, Excel, PowerPoint, and Outlook) Preferred: + Strong technical proficiency in Workday, Power BI, and Visier, and Excel + Knowledge of advanced statistical tools/languages such as SAS, SPSS, R + Functional experience in Compensation, Benefits, Payroll + Knowledge of Software as a Solution (SaaS) solutions and technology business models + Knowledge of the professional services industry is preferred Educational Qualifications Required + Bachelor's Degree and demonstrated functional and technical management experience Preferred: + Master's Degree and demonstrated compensation or financial management experience **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary The Sr. Manager, Sterility Assurance, is a highly critical role and is responsible for managing Sterility Assurance which provides support to the CAR T manufacturing site. This role is responsible for supporting facility design/modifications, the aseptic process validation program, operator qualification/requalification, the gowning certification/recertification program, critical utilities sampling and testing, and overall contamination control program for the site. The Sr. Manager Sterility Assurance is responsible to act as the SME during regulatory inspections. Duties/Responsibilities To support final product testing and release, incoming components and materials testing and release and monitoring of the critical utilities systems. Development and management of SOPs, forms, and methods required to support the compliant operation. The Senior Manager, Sterility Assurance plays a critical role in ensuring the execution and support of the contamination control strategy for the facility including, but not limited to aseptic process validation, facility design and modification, gowning, critical utilities, and EMPQs. Generates, owns, and/or supports change controls, deviations, CAPAs within the eQMS system. Support equipment, facility, and microbiological method qualifications. Ensure the site and department objectives are met. Manage and develop direct reports. Onboard new materials required to support manufacturing operations. Support manufacturing schedule and needs. Ensure employees are properly trained and qualified to perform assigned tasks, provide performance evaluations, and support career development of direct reports. The incumbent will be required to gown for entry into Aseptic core and supporting areas, on an as-needed basis. The management incumbent (or designee) will be expected to be on call, to support manufacturing issues involving sampling and/or test excursions or questions during shift operations. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. Occasional travel may be required. Perform other tasks as assigned. Qualifications Advanced knowledge of cGMP's, FDA, USP, MHRA, BP, EP, JP, PMDA, and DEA regulations and guidelines, as related to manufacture of cell therapy products. Advanced data integrity knowledge and practices. Intermediate understanding of statistics, control charts, action and alert limits and data trending. Advanced knowledge of Microbiology. Intermediate knowledge of Good Engineering Practices and Validation Principles: URS, IQ, OQ, PQ, PVs, etc. Advanced verbal and written communication skills. Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills. Must be team-oriented and has the demonstrated ability to work cross[1]departmentally throughout the manufacturing site. Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team-based environment. Advanced mentoring and coaching, influencing, negotiating and personal interaction skills. Demonstrated resource management and planning skills. Must be flexible and adaptable, and able to work under pressure, while meeting designated timelines. Advanced knowledge of safety, OSHA, and EPA regulations, electrical and energized equipment (lockout/tag out), fall safety, HAZCOM, MSDS sheets, etc. Advanced of Microsoft Word, Outlook, Excel, PowerPoint, etc. Microbiology laboratory and/or Environmental Monitoring setting. Experience working with cell therapy products is preferred. 2-3 years of leadership/managerial experience required. Experience in participating and supporting regulatory audits preferred: FDA, MHRA, PMDA, etc. Experience in working with Quality Systems preferred: SOPs, Change Control, Deviations, CAPAs, and Risk Assessments. An equivalent combination of education and experience may substitute If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Summit West - NJ - US: $121,070 - $146,703 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit ************************************* Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients' lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at ***************************************** Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at ********************. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1596592 : Senior Manager, Sterility Assurance

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary The Senior Manager, Sterility Assurance plays a critical role in safeguarding the integrity of Cell Therapy manufacturing by ensuring robust contamination control strategies and aseptic practices across the global network. This position drives compliance with international regulations and internal standards to enable the safe delivery of CAR-T therapies-products that cannot undergo terminal sterilization. Serving as a key liaison among manufacturing sites, Quality, Cell Therapy leadership, CMO partners, and broader BMS teams, this role provides strategic oversight and technical expertise. Duties/Responsibilities Designing aseptic training and qualification programs grounded in sound microbiological principles. Developing and publishing global sterility assurance standards. Managing change records and leading sterility assurance risk assessments. Ensuring operator aseptic technique across the network is consistently robust to mitigate contamination risks associated with manual processing steps. Rapid Response & Triage: Lead immediate containment and triage efforts for sterility breaches, including leaks, mold recoveries, and contamination events across a broad network of stakeholders. Reporting Relationship This position reports to the Director, Global Sterility Assurance in CTTO Qualifications Aseptic Training & Qualification Design and deploy microbiology-based training programs for the Cell Therapy network, ensuring alignment with current regulatory expectations and best practices. Develop and continuously improve the network aseptic qualification program (APQ) for CAR-T manufacturing operators, including periodic reviews. Compliance & Regulatory Expertise Ensure adherence to GMP, global health authority requirements, and internal quality standards. Provide technical guidance and act as SME during audits, inspections, and regulatory submissions. Risk Management & Data Analysis Conduct sterility assurance risk assessments for aseptic processes and implement mitigation strategies. Analyze trends and report internal/external 483 observations to governance forums to drive CAPAs. Strong background in statistics and trend analysis for contamination control performance monitoring. Innovation & Digital Enablement Champion innovative solutions and digital tools to enhance contamination control, aseptic oversight, and operator qualification. Collaboration & Leadership Partner with Manufacturing, Quality, and Technical Operations to harmonize aseptic practices across global sites. Excellent communication and influencing skills across a diverse, global stakeholder network. Technical Depth Sound scientific understanding of the relationship between operator technique and contamination control. Skilled in root cause analysis and investigational tools for microbiological issues in pharmaceutical manufacturing. Proven experience defending sterility assurance programs during regulatory inspections. Education/Experience/ Licenses/Certifications: MSc or BSc in Microbiology, Biology, or equivalent with 8+ years of relevant experience in aseptic processing environments. Demonstrated success with aseptic technique training in the biotech industry Proven leadership in designing training programs and implementing contamination control strategies. Strong knowledge of global regulatory requirements for aseptic processing and cell therapy manufacturing. Travel: This position requires 15-25% of travel (domestic and international) If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Devens - MA - US: $153,200 - $185,647 Madison - Giralda - NJ - US: $143,180 - $173,504 Seattle - WA: $157,500 - $190,849 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit ************************************* Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients' lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at ***************************************** Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at ********************. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1597861 : Sr. Manager/ Associate Director Sterility Assurance, Cell Therapy

Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. The Senior Manager, Employee Relations, will be a champion of Otsuka's culture and values. This role will work directly with a Senior member of the HR community, reporting to the Director, Employee Relations. This role supports the Director and our business leaders to investigate employee relations issues presented from across our US pharma business, assess risk related to employee claims, navigate change, and help to build a sustainable ER organization for the future. This role works in close collaboration with members of our Employee Relations Committee (ERC). The successful candidate will be required to monitor the effect of business decisions on people and advise management appropriately. This individual must not be afraid to challenge the status quo and must be able to present strong positions based on evidence and fact finding. The successful candidate is learning agile and able to deal with ambiguity while addressing complex issues and reaching and/or recommending clear and coherent solutions. The Senior Manager is expected to stay current on Federal and State laws that impact the company and/or the employees. They must be able to understand the potential longer-term implications related to Federal, State, or local policy changes and help formulate a position that protects the company and its interests. This position is based in Princeton, New Jersey. Otsuka maintains a hybrid work policy and Travel is expected ~15% of the time based on business needs. **** Working with our Business + Conduct investigations in response to a range of employee relations concerns, including harassment, discrimination, retaliation, workplace violence, and other violations of rules, regulations, policies, and procedures + Highly skilled in managing employee relations issues including participation in internal investigations and providing recommendations for resolution + Partner with Ethics and Compliance on issues that have larger impact beyond Employee Relations and implications to the overall business + Partner with Legal Affairs team in addressing ER-related legal concerns and HR leaders to provide counsel and facilitate prompt and effective resolution of workplace concerns + Use effective interviewing and documentation techniques and utilize the designated online case management tool for tracking + Report regularly regarding pending investigations and provide timely investigation reports with supporting documentation for all completed investigations + Collaborate with the Director of Employee Relations and HR Business Partners to provide guidance on performance management processes, including coaching, counseling, and performance improvement plans + Work with Director of Employee Relations to develop and reinforce an employee relations strategy and philosophy that provides clarity of direction, reliable measurement and clear feedback + Able to identify the longer-term impact related to case issues to provide a full view related to potential risks + Reinforce an employee relations strategy and philosophy that provides clarity of direction, reliable measurement and clear feedback + Work closely with management and employees, under the guidance of the Director of Employee Relations, to improve work relationships, amplify engagement, and increase productivity and retention + Demonstrated ability to manage multi-business employee relations needs Working with our HR Team + Conduct trainings on compliance with policies and procedures + Develop effective relationships with HR Business Partners to promote positive employee relations throughout the organization to ensure a high level of employee satisfaction and engagement + Partner with HR Centers of Excellence (COE's) which include Operations, Total Rewards, HRIS, Talent Management, Talent Acquisition, and DE&I to share insights and advice that may impact how we operate **Qualifications/ Required** Knowledge/ Experience and Required Skills: Knowledge and Experience + Bachelor's degree required. Degree in Business, Human Resources Management, or related field preferred + Understanding of HR legal compliance requirements and understanding of HR programs relative to support of business objectives required + 5+ years of substantive experience in Employee Relations as a subject matter expert- extensive experience conducting investigations, performance management (including advising managers on how to do so), making recommendations, and partnering with in-house counsel. Able to demonstrate outcomes that have led to actionable and supportive plans. + Pharmaceutical/biotech and or healthcare industry experience is preferred + Strong interpersonal, writing, communication, organizational, project management and presentation skills + Proficiency in Microsoft Office suite (Excel, PowerPoint, Word and Outlook) Required Skills + Must be able to thrive in a fast-paced, high-performance environment + Proven ability and strong influencing skills, decision making, and resilience + Comfortable with ambiguity and being a part of complex strategy discussions with team members and leaders + Strategic thinker with experience in execution of complex, cross-functional projects and programs + Compelling oral and written communicator with the ability to build relationships with senior leaders and a range of stakeholders to drive organizational change + Ability to objectively coach employees and management through complex, difficult, and emotional issues + Excellent planning, organization and time management skills, attention to detail, ability to handle multiple tasks, and work in a fast-paced, time-sensitive environment + Ability to work effectively in an environment of change and manage multiple priorities concurrently through strong project management, systems knowledge, and effective communication + Self-starter with demonstrated ability to work independently as well as in a team setting in order to build personal brand and to develop a network of relationships across the organization **Disclaimer** This is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. **Equal Opportunity Employer** Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $134,615.00 - Maximum $201,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works collaboratively with members of the global regulatory team to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations. **J** **ob Responsibilities** - Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL). - Identifies the need and obtains regulatory intelligence, researches precedent approvals and prior health authority decisions to assess applicability to support development of strategic options for assigned Otsuka products. - Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs (as applicable) within company timelines and in accordance with regulations and guidelines. - Independently manages preparation of INDs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines. - Confirms submission documents are accurate, compliant, and high-quality to allow for smooth and expeditious approvals from regulatory authorities. - Serves as the sponsor point of contact to the health authority. - Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with GRL, to determine appropriate actions to meet timelines and/or resolve issues. - Effectively manages and directs internal support staff and external consultants for assigned projects. - Interacts effectively with internal/external functional business units to gather data and develop documentation required for on-time submissions. - Works closely with GRA department to execute departmental initiatives to improve overall efficiency, quality, and/or output. - Assess and develop innovative ideas to move GRA department to address current and future challenges. **K** **nowledge, Skills, and Competencies** **K** **nowledge** - Experience working in the pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC certification a plus. **Skills** - Strong oral and written communication skills. - Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc. - Able to successfully interpret and apply regulatory intelligence to work output. - Ability to lead teams, prioritized work, proactively manage and communicate issues, scopes progress and risks throughout the project lifecycle ensuring key stakeholders are informed. - Able to establish close communications and working relationship with cross functional teams to meet business objectives. Results-oriented, entrepreneurial, and self-motivated with excellent organizational skills with ability to learn and grow. - Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS). **Competencies** See OPDC Competencies Chart (Level X) **P** **hysical Demands and Work Environment** Travel (approximately 20%) See document Physical Demands and Work environment for further requirements. **Education and Related Experience** Bachelor's degree with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (e.g., clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Under the direction of the Director/Associate Director of Clinical Management, the Senior Clinical Study Manager is responsible for the oversight and management of Otsuka clinical studies, including coordination with other relevant parties (e.g., other Otsuka departments, external service providers (ESPs), etc.). Responsibilities include the planning, execution and completion of clinical trials according to applicable regulations and guidance; ICH Guidelines Good Clinical Practices (GCP), and Otsuka SOPs, within agreed-upon timeframes and budget. **** - Provides oversight and management of clinical studies at Otsuka, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Otsuka SOPs. - Contribute to the development and review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents. - Provide input into and approval of the identification, evaluation, and selection of CROs, outside vendors (e.g., central labs, central IRB, IVRS, etc.), and investigative sites. - Provide leadership and guidance to clinical team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Otsuka SOPs. - Communicates and coordinates clinical project-related activities and progress across all relevant cross-functional departments. - Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required. - Participate in forecasting study expenditures and resourcing needs. - Ensure internal clinical team and vendors manage and monitor study-related budget and expenses to meet forecast. - Provide timely communication of any variances in budget forecast to the Director/Associate Director. - Establish communication flow with CRO and investigative sites to maximize compliance with study protocol. - Provide oversight of ESP in its conduct of the day-to-day operations of assigned trial(s), as assigned. - Participates in ongoing review of clinical trial data focusing on data integrity, trending and consistency. - Supports project level inspection readiness activities, including responsibility for ensuring the completeness, timeliness and quality of the TMF. - Serve as Clinical Management representative for review of protocols within and across portfolios, as assigned. - Participate in program-level risk mitigation strategies and collaborate with ESPs on study-level risk mitigation and management activities. - Represent Clinical Management in departmental and cross-functional initiatives, as assigned. - Leads and/or contributes to assigned departmental, ESP and corporate standardization and continuous improvement efforts. - May have supervisory responsibilities including: + Coordinating the training and onboarding of new employee(s) on corporate culture, corporate goals/vision and departmental policies and processes. + Assuring compliance with departmental, SOP, compliance, and corporate training + Ensuring assigned staff have access to all required materials, systems, and training to complete job responsibilities. + Setting clear performance expectations and individual development plans and providing specific and frequent feedback to the employee on his/her performance. - Performs other duties, as assigned. **Qualifications/ Required** Knowledge/ Experience and Skills: - Comprehensive knowledge of clinical operations, drug development process, roles, and responsibilities of individuals within the project team, standard operating procedures (SOPs) and GCP/ICH regulations. - Thorough knowledge of contract research organizations (CROs), outsourcing, and evaluation of work performed against vendor Statement of Work (SOW). - Strong understanding of the clinical and scientific basis for assigned clinical program, with the ability to translate that knowledge in operational management. - Strong understanding of global regulatory requirements. - Strong communication, organization, planning, analytical, problem solving, and people management skills. - Demonstrated experience with working with the Microsoft suite of programs (e.g., Word, Excel, PowerPoint, Outlook, etc.) - Good understanding of clinical trial related software (e.g., eCRFs, IRT, CTMS, etc.). - Ability to travel up to 25%. **Educational Qualifications** Required: - Bachelor's Degree or Registered Nurse (RN). Minimum of 10 years industry experience with seven (7) years in clinical trial management experience. Preferred: - Previous supervisory experience. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

About the Department Our Marketing & Patient Solutions group creates and delivers human-centered experiences, where innovation meets customer-centricity, driving the ultimate experience for our patients. Our focus extends beyond transactions to craft experiences as one fully integrated, aligned and connected organization that puts empathy at the center, powered by insight and foresight. We develop an end-to-end approach to strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our strategies are rooted in a deep understanding of customer needs and behaviors. Our 'test and learn' mindset and approach enables us to iterate rapidly and refine our strategies based on real-world results. We are building an intentional team culture that is made up of diverse skillsets, united by the shared belief that reinvention and learning is what fuels continuous growth. Do you get excited about exploring the unknown? Does the idea of driving value through human-centered design pull you in? Are you ready to experiment with us? **This is not a remote opportunity. Must be available to come in the office 5 days a week. The Position The Senior Manager, Enterprise Insights, provides insights primary market research to help guide Novo Nordisk on portfolio, franchise, and brand strategy development and execution. The role supports specific brands and therapy areas, and provides holistic, insight-driven consultation and evidence-based strategic and tactical guidance to all levels of marketing stakeholders. In addition to Marketing, this role partners with other stakeholders and Enterprise Insights teams to ensure proper alignment and impact on Novo Nordisk's business. Relationships Reports to a Director or Senior Director in Enterprise Insights and will act on behalf of this role in certain situations. H as frequent interaction with - and may indirectly manage on a day-to-day basis - the work of one or more NN Global Business Services offshore team colleagues. Interact directly and frequently with stakeholders in Marketing and owns the relationship with these on behalf of Enterprise Insights . Also interacts with other stakeholders across the NN organization. In addition to internal relationships mentioned above, external relationships include interactions with professional services and consultants. Essential Functions + Design and execute primary market research to uncover opportunities and mitigate risks associated with the core strategic priorities of the Brand + Identify business challenge or opportunity in direct collaboration with key stakeholders. Scope, plan and execute analyses to answer business question. Build a story and presentation with recommendations on how address the challenge or opportunity. + Create holistic views of the market situations and the opportunities and challenges for our business, through analyses utilizing our various data set and market research studies. + Guide the brand teams and other stakeholder in their strategic and tactical decisions, through recommendations in presentations, meetings, and workshops. + Drive and manage projects and initiatives to create greater impact of our sales and marketing effort. Physical Requirements Approximately 0-5% overnight travel. Qualifications + Bachelor's degree required. MBA, M.Sc., or other advanced degree preferred. + 6 years of relevant work experience preferred + Strong analytical, quantitative, and qualitative analysis skills required + Strong Microsoft Office skills - especially Excel and PowerPoint required. Experience with Tableau preferred + Primary Market Research experience preferred + Experience working with IQVIA data preferred + Creative problem solving; ability to organize/manipulate data and see big picture from scattered pieces of information + Strong writing, presentation, project management skills required + Demonstrated ability to managed multiple projects with conflicting deadlines + Positive and eagerness to learn, collaborate and partner with internal business colleagues We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger - a legacy of impact that reaches far beyond today. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at **************. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.