Sumitomo Corporation jobs - 30 jobs

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. The Associate Director, RBQM, provides study-level leadership for risk-based quality management across Phase 1-4 oncology clinical trials. Reporting to the Executive Director, Data Management, this role drives data-driven quality oversight, ensuring clinical trial risks are proactively identified, monitored, and mitigated in alignment with regulatory expectations and Sumitomo Pharma America quality standards. **Job Duties and Responsibilities** + Plays a key role in facilitating understanding of the SMPA RBQM Strategy within Clinical Project Teams by providing targeted training sessions and ensuring alignment across team members. + Lead and facilitate cross-functional risk assessment meetings. + Maintain comprehensive and traceable documentation of all risk assessment activities, mitigation decisions, and quality parameters, ensuring periodic review and updates as required. + Own the development, maintenance, and ongoing updates of Risk Assessment Categorization Tools (RACT) and Quality Risk Management Plans (QRMP) for assigned studies. + Ensure alignment of functional study plans with approved risk assessment and quality parameter documents + Ensure alignment of study risks with Critical to Quality (CtQ) factors, protocol requirements, and data quality objectives. + Partner closely with Data Management and Biostatistics to define, implement, and monitor KRIs and QTLs. + Partner closely with Director Clinical Operations, Oncology, including RBQM central monitoring as part of the overall monitoring strategy. + Lead the execution of centralized monitoring strategies, including ongoing data review, signal detection, and trend analysis. + Provide expert guidance on targeted SDV and targeted SDR approaches based on evolving risk profiles. + Interpret complex clinical and operational datasets to identify emerging risks and recommend mitigation strategies. + Develop and deliver risk analytics, dashboards, and trend presentations to Clinical Project Teams and functional leadership. + Act as the RBQM subject matter expert within Data Management, providing consultation and guidance to cross-functional stakeholders. + Support inspection readiness by ensuring RBQM rationale, documentation, and decisions are inspection-ready and defensible. + Contribute to the continuous improvement of RBQM processes, tools, and standards across Data Management. + Maintain high proficiency in systems and technology as applicable to RBQM monitoring analytics and data access. + Contribute to the SMPA technology strategy, including serving as business lead for specific technology. + Ensure all risk assessment and quality management activities are conducted in accordance with related company SOPs, including documentation, approval, and filing requirements. + Manage direct line reports, providing guidance, mentorship, and performance feedback to ensure their professional growth and the successful execution of their responsibilities. **Education and Experience** + Bachelor's or advanced degree, preferably in life sciences, data analytics/ technology, or a related field. + 8+ years of progressive experience in clinical development, data management, clinical quality, or RBQM. + Demonstrated experience supporting or leading oncology clinical trials across Phase 1-4. + Hands-on experience with TransCelerate RBQM frameworks, including RACT and QRMP ownership. + Proven ability to lead risk assessments and influence cross-functional teams without direct authority. + Experience implementing centralized monitoring, KRIs, QTLs, and risk-based SDV/SDR strategies. + Experience operating effectively in a matrixed, global environment. + Experience supporting regulatory inspections or audits related to RBQM. + Familiarity with centralized monitoring platforms and data visualization tools. + Experience contributing to functional or enterprise-level RBQM initiatives. The base salary range for this role is $155,200 to $194,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill, Compeed, Solpadeine, NiQuitin, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging. Join us on our One Perrigo journey as we evolve to win in self-care. Description Overview Perrigo Company is dedicated to making lives by bringing high quality and affordable self-care products that consumers trust everywhere they are sold. Help us do it. We are currently looking for a highly motivated Manufacturing Associate who will work the Night shift from 6pm - 6am ET on a rotating 2/2/3 schedule (Week A: Mon, Tues, Fri, Sat; Week B: Sun, Weds, Thurs). This position pays between $21.00 - $22.00/hour depending upon experience + a 15% shift premium! A comprehensive benefits package including, but not limited to, health, dental, vision, 401K with match, quarterly bonus, and more is also offered by Perrigo. Scope of the Role * Operates and ensures proper operation of manufacturing equipment. * Conducts regular in-process checks of quality attributes of materials and products and to ensure the equipment is operating correctly. * Assists in recording accurate production and inspection data and is responsible for completing manufacturing paperwork in compliance with required SOPs and cGMPs. * Performs set ups, changeovers and cleans the work area throughout the shift to ensure proper clearance of materials. * Continuously looks for and helps to implement improvements to the process, productivity, quality and reduce costs. * Performs other related duties as assigned. Experience Required * High School Diploma or Equivalency required. * Must possess basic math and reading comprehension skills and be able to read, speak and comprehend instructions in English, including procedure documents, as well as proofread alpha and numeric data. * Requires ability to follow standard work and Standard Operating Procedures (SOPs). * Basic computer skills and the ability to navigate through computer based training systems and use in the course of daily work may be required. * Must be able to communicate effectively as a member of a work team. * Must meet all locally defined training requirements. * Experience in a pharmaceutical, Federal Drug Administration (FDA) controlled, other controlled regulatory agencies, or Current Good Manufacturing Practices (cGMP) packaging or manufacturing environment is preferred. * Required to operate and handle material handling equipment. * Ability to work overtime as required. Essential Functions of the Job Physical Requirements: * Consistently/Frequently - Sit, walk, lift 50 lbs., pulling and pushing, grasp, move items, feel with hand/fingers * Occasionally - Stand, climb stairs/ladders, stoop/bend, squat, kneeling, twisting, reach, reach above shoulders and head * Rarely - Lift above shoulders and head 25 lbs. Environmental: * Consistently/Frequently - exposure to loud noises/machinery and exposure to chemicals * Occasionally - exposure to hot conditions including room temperatures of 90+ degrees Fahrenheit. Other Qualities: * Consistently/Frequently - see (vision), ability to see colors, hear, ability to read and write, ability to interpret information, basic math, reading and writing in English. * Simple problem solving may be required to adjust process parameters based on data readouts and machine feedback and document corrections to batch records and other controlled documents using cGMP-compliant practices. * Simple decision-making skills are expected to read and interpret work instructions and SOPs and then decide on appropriate courses of action based on the guidance provided. Benefits We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally. Find out more about Total Rewards at Perrigo. Hybrid Working Approach We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles. We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo Nearest Major Market: Dayton Nearest Secondary Market: Cincinnati

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. We are currently seeking a dynamic individual who will serve as administrative support to the Legal Department, responsible for performing legal administration activities, supporting process improvements, and identifying operational efficiency opportunities across the legal function. This role is essential in ensuring the department operates with optimal effectiveness, aligning with the broader goals of the organization. **Job Duties and Responsibilities** _Process Improvement & Operational Efficiency_ + Identify, design, and implement scalable legal processes and workflows to improve efficiency and reduce risk. + Support all aspects of setting up and maintaining purchase orders. + Support work orders and invoicing under intercompany and external vendor agreements. + Obtain and submit accruals from external vendors in compliance with applicable laws. + Support Chief Legal Officer's direct reports with meeting scheduling and expense reports. + Review and distribute mail in compliance with company data retention schedule. + Manage Legal Teams channel and filing site in compliance with company data retention schedule, and to ensure consistent organizational structure and efficient access to information. _Project & Vendor Management_ + Support legal department projects and initiatives (e.g., system/process implementations, restructuring activities), including timelines, deliverables, and stakeholder communications. + Retrieve contracts from and uploading contracts to ECMS (CLM). + Oversee relationships with external counsel and legal vendors, including ensuring engagement letters are in place and on file, and POs in place. + Monitor legal spend and support budgeting, forecasting, and cost-saving initiatives. _Compliance & Governance_ + Support corporate governance activities, including board documentation, policy development, regulatory filings, and entity restructuring. + Ensure legal operations align with pharmaceutical compliance standards and industry regulations. _Team Collaboration & Communication_ + Act as a liaison between legal and other departments to ensure seamless legal service delivery. + Support preparation of PowerPoint presentations. **Key Competencies** + Experience supporting legal teams in a regulated industry. + Ability to manage multiple priorities in a fast-paced environment. + Strategic thinker with a continuous improvement mindset. + Comfortable working with senior leadership and cross-functional teams. **Education and Experience** + Bachelor's degree required; paralegal certification preferred. + 3-5 years of experience in legal administration with some operational experience + Demonstrated experience in process improvement, project management, and cross-functional collaboration. + Proficiency in legal tech platforms (e.g., CLM (ECMS/iCertis), e-billing, Oracle, SAP, Workday, PowerPoint, Word, Excel) preferred. + Excellent organizational, analytical, and communication skills. The base salary range for this role is $62,600 to $78,200. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, overtime, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes up to 120 hours of vacation per year, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter and access to our service recognition program. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. We are seeking a highly skilled and collaborative **Senior Manager, Web Development** to lead the design, development, and support of our company's external web properties. This includes websites supporting Marketing, Corporate Communications, and Medical Affairs. The ideal candidate combines front-end development expertise with excellent communication and leadership skills to translate business needs into elegant, secure, and scalable web solutions. **Key Responsibilities** + Lead the Web Services team in building and maintaining public-facing websites on the AWS platform using Vue.js and Nuxt frameworks. + Partner with business stakeholders across Marketing, Corporate Communications, and Medical Affairs to gather requirements, propose solutions, and ensure align with corporate branding and compliance standards. + Oversee the full web development lifecycle - architecture, development, testing, deployment, and ongoing optimization. + Manage vendor and agency relationships for specialized design, content, and quality assurance. + Ensure web solutions adhere to industry best practices for security, accessibility (WCAG), SEO, and performance. + Champion agile delivery practices and modern CI/CD pipelines to ensure quality and efficiency. + Mentor front-end developers and establish coding standards and development best practices. + Stay current with emerging web technologies, frameworks, and regulatory guidance relevant to pharmaceutical digital content **Required Qualifications** + Bachelor's degree in Computer Science, Information Technology, or a related field (or equivalent experience). + 8+ years of experience in front-end web development, including Vue.js, Nuxt, Node.js, JavaScript, HTML5, CSS3, Tailwind CSS, GitHub, ColdFusion, MySQL. + 3+ years in technical leadership or management role overseeing web development projects and managing development teams. + Hands-on experience deploying and managing web applications on AWS (e.g., CloudFront, S3, Lambda, API Gateway). + Experience integrating web platforms with analytics tools (Google Analytics, Google Tag Manager, Google Search Console) and tag management systems. + Strong understanding of responsive design, accessibility standards, and SEO principles. + Proven ability to coordinate various timelines, cross-functional teams, and external resources to meet deadlines. + Excellent communication and collaboration skills, with the ability to translate technical concepts for non-technical stakeholders. + Proven track record managing multiple projects and priorities simultaneously in a fast-paced environment. + Exceptional attention to detail and a commitment to delivering high-quality, error-free solutions. + Experience within the pharmaceutical, biotech, or healthcare industries. + Familiarity with digital content approval workflows (e.g. Veeva PromoMats or equivalent). The base salary range for this role is $140,900 to $176,100. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Scientist II. This position will be part of the Translational Research and Medicine-Oncology team, with a primary focus on advancing translational research to support oncology programs in clinical trial stages. This individual will be responsible for designing, oversighting, and interpretating translational studies to understand mechanism of action, resistance pathways, and potential new indications. The candidate may also be involved in biomarker analysis to support these translational objectives. **Job Duties and Responsibilities** + Develop hypotheses by integrating insights from scientific literature, preclinical and clinical data + Design experiments to support identification of mechanism of action, resistance mechanisms, and potential indications + Manage translational research and biomarker studies conducted with CROs and academic investigators to ensure high-quality, timely delivery of data + Maintain organized, detailed logs of studies and data to ensure accuracy, reproducibility, and compliance with regulatory standards + Present data and insights in internal meetings and cross-functional program team discussions **Key Core Competencies** + Scientific curiosity with ability to generate and test hypotheses that inform drug development + Excellent problem-solving and critical-thinking skills to interpret complex data + Strong organizational skills and attention to detail in managing studies, data, and documentation + Strong project management and vendor oversight skills + Adaptability and resilience in a fast-paced, evolving research environment **Education and Experience** + PhD degree in a related field of science (Biology, Biochemistry, Molecular & Cellular biology, Cancer Biology, Immunology) + 1-3 years of postdoctoral or industry research experience + Familiarity with oncology research preferred + Experience with common biomarker platforms (e.g. NGS, flow cytometry, IHC) preferred The base salary range for this role is $102,000 to $127,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

GROW WITH US: Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We'd love for you to team up with us to “innovate every day,” put “people first,” and take the “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry. STAY AWESOME: Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology - an advanced predictive algorithm that automates insulin delivery. But we're so much more than that. Our company's human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com A DAY IN THE LIFE: As part of the field sales team, and in partnership with your Territory Manager, you'll provide continuing education and pump training to patients, customers, and health care professionals on patient use of insulin pump therapy. You'll take the lead in conducting educational classes that support diabetes education and advanced diabetes management skills and be given the opportunity to co-develop successful strategies with your field partner to address clinical concerns within the sales territory. Your goal, alongside your Territory Manager, will be to ensure your territory is directly impacting both patient and provider success. The ideal candidate will reside in Toledo Proper or Alvada Ohio, A Clinical Diabetes Sales Specialist at Tandem also: Develops successful strategies with assigned Territory Manager to address clinical concerns in the sales territory to ensure the sale of Tandem Diabetes products and to ensure the retention of existing relationships. Efficiently uses available tools and resources to identify sales leads and gather the information required to determine if prospecting criteria have been satisfied. Effectively promotes Tandem's unique market position and creates value for the health care professionals by differentiating Tandem Diabetes Care products and clinical services. Educates prospects/customers regarding industry/healthcare trends, web-based solutions, Tandem products, services and outcomes, and/or other population health management issues. Completes all product training, documentation and communication with HCPs in a thorough and timely manner per company policy. Establishes and maintains excellent professional relationships with health care professionals to support the sale of Tandem Diabetes products. Responsible for initial and ongoing recertification of contracted and non-contracted Tandem Pump Trainers in the territory. Collaborates with Customer Technical Support Specialists and Clinical Support Specialist team to identify and address post-sale product issues, and additional patient education training needs. Keeps records updated in the customer relationship management software (CRM), for all business dealings within assigned territory. Establishes and maintains a territory call cycle that will minimize administrative time and maximize time and effort spent with sales prospects and customers. Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements. Directly reports to the Regional Sales Manager (RSM) for all sales and business process responsibilities and goals and maintains a strong partnership with the Regional Clinical Manager (RCM) for clinical responsibilities, goals and compliance. WHAT YOU'LL NEED: RN (BSN preferred), RD or RPh or equivalent combination of education and applicable job experience Advanced Diabetes Education Professional Credential (Certified Diabetes Care and Education Specialist (CDCES) or Board Certified, Advanced Diabetes Management (BC-ADM) certified or eligible) 2-years' experience coordinating and conducting patient education on the technical use of diabetes technology (experience with video remote education preferred) Ability to relate effectively with patients, referral sources and health care professionals. Demonstrated ability to effectively communicate as a clinical expert on diabetes, diabetes technology, Automated Insulin Delivery, and diabetes management software systems to patients and health care providers. Skilled at presenting educational material in a clear, concise manner to various audiences. Ability to work in a fast paced, ever changing market and see change as an opportunity to improve business performance and campaigning for it when necessary. 1-year related diabetes/endocrinology industry experience preferred Ability to travel at least 80% in your assigned territory; must maintain a valid driver's license and required auto insurance as well as good driving record per company policy COMPENSATION & BENEFITS: COMPENSATION & BENEFITS: The base pay for this position is $98,100 - 119,900 annually, with a target earning potential of $123,100 - 144,900 annually. Base pay will vary based on job-related knowledge, skills, experience and may also fluctuate depending on candidate's location and the overall job market. In addition to base pay, Tandem offers a competitive compensation package that includes a robust benefits package. Tandem offers health care benefits such as medical, dental, vision, health savings accounts and flexible saving accounts. You'll also receive 11 paid holidays per year, a minimum of 20 days of paid time off (starting in year 1) and have access to a 401k plan with company match. Learn more about Tandem's benefits here! YOU SHOULD KNOW: Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a thorough screening process comprised of a drug test (excluding Marijuana) and background check, which includes a review of criminal history information. Tandem has good cause to conduct a review of criminal history for this position as this position will have access to customer's protected health information and regular contact with customers. This review is required to ensure that individuals in such roles uphold high standards of trust and integrity so as to protect the interests of our customers, employees, and stakeholders. Sponsorship: Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. WHY YOU'LL LOVE WORKING HERE: At Tandem, we believe joy fuels excellence. That's why we've built a workplace that celebrates your achievements and supports your well-being. Our team thrives on pushing boundaries and fostering growth, all while maintaining a spirit of fun and camaraderie. This is just one of the ways we stay awesome! Explore the benefits and reasons to love Tandem at *************************************** BE YOU, WITH US! We embrace the value that every single one of us brings to the table. But sometimes we forget that when we don't meet 100% of a job description's criteria - maybe you're feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us. Tandem is firmly committed to being an equal opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marriage/civil partnership, pregnancy/maternity, or sexual orientation. We are an inclusive organization, and we welcome applications from a wide range of candidates. Selection for roles will be based on individual merit alone. REFERRALS: We love a good referral! If you know someone who would be a great fit for this position, please share! APPLICATION DEADLINE: The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications. Make a move that matters. Join Tandem Diabetes Care, where we're turning challenges into triumphs every day and where your talents will help shape a healthier, happier tomorrow. #LI-Remote #LI-KL1

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Key Responsibilities Strategic & Solution Leadership + Serve as the Solution Owner and functional expert for integrated systems, including SAP S/4HANA, SAP CGTO, Salesforce ATM, and Enterprise MDM. + Define the architecture, solution design, and technical roadmap for critical GxP systems supporting Clinical Supply Chain, Commercial Operations, Quality Management, and Manufacturing. + Lead the integration strategy and execution between SAP S/4HANA (covering Supply Chain, Finance, and Manufacturing), Salesforce ATM (for Patient/Order/Cell Orchestration), SAP CGTO, and other GxP systems. + Translate complex business requirements related to Chain of Custody (CoC) and Chain of Identity (CoI)-crucial in CGT-into compliant and scalable system solutions. GxP, Quality & Compliance + Own and enforce GxP compliance for all in-scope applications, ensuring all system activities meet requirements for validation, change control, documentation, audit trails, and data integrity. + Directly manage the System Development Life Cycle (SDLC) for regulated systems, including validation planning, executing IQ/OQ/PQ protocols, and final report generation. + Act as the primary point of contact during regulatory inspections and internal GxP audits related to the managed systems. + Establish and govern processes for Master Data Quality and Governance across the enterprise, ensuring data integrity is maintained for GxP-critical data elements. Management & Execution + Lead and mentor a cross-functional team of business analysts, functional consultants, and system integrators. + Oversee project execution, managing scope, budget, resources, and timelines for major system initiatives and enhancements. + Manage vendor relationships and service delivery for external partners involved in system implementation and support. Required Qualifications Experience & Functional Expertise + 8+ years of experience in implementing and managing enterprise systems within the Pharmaceutical, Biotech, or Cell/Gene Therapy industry. + Proven expertise in leading major transformation projects involving SAP S/4HANA (Sourcing, SC, QM, MM, SD modules). + Direct, hands-on experience with Salesforce Health Cloud and/or Advanced Therapy Management (ATM), particularly concerning patient and cell journey orchestration. + Deep practical knowledge of GxP regulations (21 CFR Part 11, GAMP 5, etc.) and demonstrated experience validating regulated computer systems. + Strong understanding of Master Data Management (MDM) principles and experience implementing an MDM solution in a regulated environment. + Specific knowledge of CGT processes, including CoC/CoI, apheresis, vector manufacturing, and final product distribution, is highly desirable. Education & Technical Skills + Bachelor's or Master's degree in Computer Science, Engineering, Life Sciences, or a related field. + Exceptional ability to manage system integration complexity, with a background in technologies like SAP CPI platform. + Outstanding leadership, communication, and stakeholder management skills, with the ability to articulate complex technical concepts to a non-technical audience. The base salary range for this role is $125,600 to $157,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated individual for the position of **Multi-Specialty Portfolio Specialist/Associate Portfolio Specialist.** This position is being posted at multiple levels. Applicants for this position will be considered for the titles listed in this posting. The title and salary will be determined by the experience and qualifications of the final candidate. Candidates who do not meet all of the qualifications may be considered for an Associate level role. In this field-based role, the **Multi-Specialty Portfolio Specialist/Associate Portfolio Specialist** will focus on achieving sales goals within primary care, urology, and the women's health therapeutic area in an assigned geographic territory. This individual will have a proven record of success within specialty biopharmaceuticals. They will be highly collaborative, tactical, energetic and thrive in a nimble organization. The **Multi-Specialty Portfolio Specialist/Associate Portfolio Specialist** , will demonstrate a sense of urgency to prepare and successfully execute a new product launch plan for their assigned geography. The **Multi-Specialty Portfolio Specialist/Associate Portfolio Specialist** , will drive results that are consistent with the company's goals, mission, and values. **Job Duties and Responsibilities** Deliver Results + Consistently meet or exceed sales objectives by leading and implementing effective sales strategy in an ethical and compliant manner + Demonstrates resilience and consistent ability overcome obstacles to achieve objectives + Consistently demonstrate SMPA Values Business Planning and Execution + Develop and execute an effective business plan aligned to sales strategy to achieve sales results + Prioritize and call on the appropriate customers at the optimal frequency to change prescribing behaviors + Demonstrate effective pre-call planning prior to HCP engagement to establish a clear purpose for the sales call Impactful Selling + Move customers along the adoption continuum by driving market share growth + Demonstrate two-way dialogue with customer interactions by employing selling skills to generate dialogue, identify customer needs and active listening + Effectively utilize patient type selling with approved messaging and resources Infinite Mindset + Deploy growth mindset daily + Focus on opportunities not limitations + Expect success **Key Core Competencies** + Has a proven, consistent track record of exceeding sales goals in assigned geography or relevant experience. + Proven to be successful in all aspects of selling, i.e., clinical expertise, selling skills, and an in-depth understanding of the local ecosystem or relevant experience. + Understands, analyzes, and effectively presents scientific/technical details and marketing materials. + Proficient knowledge and understanding of the payer landscape including commercial, Medicaid, and Medicare or relevant experience. + Demonstrates the ability to analyze complex data to develop strategic and actionable business plans to deliver sales results. + Candidates must have excellent communication & organizational skills and be proficient with technology platforms and business hardware/software. **Education and Experience** + Bachelor's Degree is required, preferably in Business or Life Sciences. + Generally, the **Associate Portfolio Specialist** will require 0 - 3+ years of pharmaceutical sales experience and/or relevant experience. Demonstrated mastery or the aptitude to learn, product and disease state knowledge. + Generally, the **Portfolio Specialist** will require 3 - 5+ years of pharmaceutical sales experience and/or relevant experience. Demonstrated mastery or the aptitude to learn, product and disease state knowledge. + Travel within territory is required, which may include both car and overnight air travel depending upon territory. + Some national travel to corporate headquarters, training, product theaters and sales meetings is required on a periodic basis. + Work hours may include meetings scheduled outside of normal working hours. The base salary range for this role is $108,000 to $135,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Manager, Clinical Systems R&D IT Business Applications** who will serve as the primary liaison between R&D Clinical Operations team and IT, responsible for the delivery and support of technology solutions that align with business needs and operational demands. **_This role requires proficiency in implementing, integration, and managing Medidata & Veeva clinical systems (e.g. CTMS, EDC etc.) in a regulated environment_** **Job Duties and Responsibilities** + Partner with Clinical business stakeholders to co-create technology plans which support their business objectives and operational demands + Continuously assess current systems environment and identify changes (process and/or system) that enhance effectiveness + Assist in the evaluation of new technology systems and/or service providers + Oversee end-to-end management of IT projects-including planning, design, and implementation-ensuring projects are delivered on time, within scope, and with measurable business impact + Work with a team of managed service providers supporting the lines of business technology needs including project delivery, solution design, enhancement requests and support services + Accountable for managing clinical application systems through their full lifecycle, from implementation to ongoing optimization + Lead and initiate troubleshooting quality and/or functionality issues associated with technology systems in scope + Develop and maintain comprehensive project documentation, ensuring centralized storage and accessibility for knowledge management + Manage and prioritize system enhancements and fixes in collaboration with business stakeholders + Provide regular project status reports, manage issues proactively, and adjust schedules as needed while maintaining alignment with the overall program plan + Responsible for timely execution of all GxP system commitments and compliance activities (Backup recovery, Disaster Recovery testing etc.) + Collaborate with cross-functional IT teams to ensure seamless delivery of services, efficient communication, and shared accountability for outcomes + Establish clear performance metrics and service level agreements (SLAs) to monitor IT service delivery, project outcomes, and stakeholder satisfaction + Stay informed of emerging industry trends, best practices, and regulatory changes to proactively recommend technologies and process adaptations that empower the company during phases of rapid expansion + Serve as the IT subject matter expert for application upgrades, integrations, and system enhancements across supported business areas **Key Core Competencies** + Strong understanding of Clinical business processes, requirements and technology systems supporting Clinical Trials (e.g. EDC, CTMS, ETMF, Payments etc.) + 7+ years of progressively increasing experience managing clinical applications in a Pharma/Biotech company + Strong understanding of building and operating a technology support function + Proficient in implementing, integration and managing Medidata & Veeva clinical systems (e.g. CTMS, EDC etc.) in a regulated environment **Education and Experience** + BS/BA degree in a related discipline is required. Training or equivalent experience in IT or business management is beneficial but not required + 7+ years of experience in life sciences with a focus on IT system delivery + 5+ years of experience in implementing, integration and managing Medidata & Veeva clinical systems (e.g. CTMS, EDC etc.) in a regulated environment + Experience in Program & Project Management, including the Software Development Lifecycle and Computer Systems Validation process + Excellent communication skills The base salary range for this role is $127,440 to $159,300. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Associate** **Medical Director, Clinical Development - Oncology** . The associate medical director is responsible for the leadership, development, and management of clinical studies while building and maintaining relationships with investigators and key opinion leaders. **Job Duties and Responsibilities** + Lead and demonstrate ownership of the design and implementation of a clinical development program or programs in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, markets, business operations, and emerging issues. + Oversee project-related education of investigators, study site personnel, and study staff. + Responsible for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of safety and efficacy data. + Present at scientific, medical, and regulatory meetings globally. + Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOL's, and patient advocacy groups. + Contribute to company's planned regulatory filings including authoring clinical sections for INDs, NDAs, and other related documents. + Partner with Drug Safety & Pharmacovigilance to assess the safety profile of compounds. + Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators, and internal stakeholders. + Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives. + Maintain ethical standards of the highest level and have the knowledge and ability to comply with all relevant ethical, regulatory, and legal standards. + May participate in or lead clinical development contributions to due diligence or other business development activity. + As required by program needs, contribute in partnership with Discovery colleagues to the design and implementation of translational strategies. + Participate in meetings and committees of parent company or other affiliates. + Establish collaborative and productive relationships with the parent company, internal/external partners, and relevant affiliates. + Work in close collaboration with the late-stage development group. + Perform other duties as requested. **Key Core Competencies** + Ability to run a complex clinical research program with minimal direction + Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols + Proven leadership skills and ability to bring out the best in others on a cross-functional team; highly collaborative, team-oriented, and decisive + Able to lead through influence + Excellent communication and presentation skills are essential. + Identify the key competencies or attributes required to excel in the role. + Examples may include problem-solving, teamwork, communication, etc. + Highlight any specific qualities or traits that are important for success in the role. + These could include attention to detail, adaptability, creativity, etc. **Education and Experience** + Medical Doctor (MD), Doctor of Osteopathy (DO), or non-US equivalent of MD + Completion of a residency program strongly preferred + Completion of a subspecialty fellowship is desirable + Experience in blood cancers or solid tumors desirable + 0 to 5 years of pharmaceutical drug development experience required. The base salary range for this role is $187,900 to $234,900. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced leader for the position of **Vice President, Regulatory Affairs Oncology** . The candidate must be deeply experienced in Oncology. In addition, the candidate must have recent Oncology NDA submission experience and submissions worldwide including HTA submissions. The individual will be responsible for leading development of all non-clinical and clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international submissions. In addition, the candidate must be experience with supporting all aspects of global commercial product. The role will hold accountability for regulatory submissions, applicable communications, and compliance across the company's new and established programs. This position reports to the Chief Medical Officer. **Job Duties and Responsibilities** + Strategic thought partner including with but not limited to VP Clin Dev and CMO + Manage Commercial Regulatory Affairs function and serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the advertising and promotion of prescription drugs + Guide and/or lead regulatory agency interactions, including communications and meetings + Provide strategic and operational leadership to the Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the development of advertising and promotion in accordance with business goals and objectives, regulations, guidelines, and company policy. + Manage and/or support the development and implementation of policies, procedures and tools related to advertising, promotion, and labeling + Manage compliance and risks related to R&D activities, especially activities of regulatory affairs, (e.g., SOPs) + Set clear standards and expectations for the accurate and timely reporting of status of all regulatory affairs activities; provide relevant input to Leadership + Oversee the regulatory activities at CROs, providing document review in order to ensure the quality and scientific integrity of documents submitted to regulatory authorities + In collaboration with Commercial, Medical and Legal colleagues, conduct a detailed review and evaluation of the adequacy of clinical evidence provided to support proposed claims and assess consistency of proposed claims with FDA-approved labeling + Provide regulatory leadership to the respective cross-functional teams charged with advertising and promotion review to ensure compliance of promotional materials including, but not limited to, Physician and Patient Sales, Marketing and Educational Materials, Training Materials, Slide Presentations and press releases and external communications in compliance with FDA regulations and Company policies + Serve as the regulatory member of the scientific Medical Review Committee (sMRC) to ensure regulatory compliance for medical based communications, congresses, and ad boards. + Serve as primary contact leading and facilitating communications with the OPDP reviewers in the request and negotiation of advisory comments and any other interactions regarding use of promotional claims for assigned products, including pre-clearance of launch materials. + Direct and ensure the timely submission of all applicable approved promotional materials to the FDA on Form 2253s + Ensure compliance of labeling, promotional and educational materials with governing Health Authorities. + Managing responsibilities for direct reports within the commercial regulatory team for both product promotional review and product promotion submissions to FDA for both women's health and prostate cancer + Recruits, develops, manages and mentors regulatory professionals and drives a culture of excellence and motivates employees to perform at their highest ability. Rewards and recognizes employees and teams who take initiative beyond expectations to advance business goals + Provide leadership and direction to clinical regulatory. Provide coaching and development and drive a culture of excellence that motivates employees to perform at their highest ability. Rewards and recognizes employees and teams who take initiative beyond expectations to advance business goals. **Key Core Competencies** + Demonstrate communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively + Exercise good judgment and make decision that is appropriate for the organization + Results-driven, take initiative and ownership to accomplish work + Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment + Strive for continuous improvement and embrace innovative ideas in daily work + Demonstrate coaching skill to inspire, develop, and motivate team + Thought leader with track record to formulate and integrate functional strategies with corporate objectives and translate them into actionable deliverables. + High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture **Education and Experience** + Advanced degree in a relevant scientific discipline required. + Doctoral degree (MD, PharmD, or PhD) preferred + 15 years of biopharmaceutical experience, which include at least 10 years of direct experience in Regulatory Affairs in Oncology + Demonstrated experience in preparing strategies for and submitting applications for drug or biologic products (INDs, NDAs, MAAs) + NDA Experience in Oncology required + Demonstrated leadership skill leading a functional team + Comprehensive knowledge and interpretive understanding of global regulations and guidelines (nonclinical, clinical, labeling, promotional) + Strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (eg, changing regulatory environment, new competition, shifting market environment) along with the ability to balance short-term needs with long-term vision. The base salary range for this role is $280,560 to $350,700. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Position Summary** The Business Applications team is part of IT and is responsible for supporting, developing, managing and enhancing the capability of enterprise applications which make up the platform that delivers SMPA's business processes. The Manager, Enterprise Apps, Workday Architect is responsible for partnering with HR to architect the company's HR applications including Workday and other integrated HR platforms (e.g., benefits, time tracking, learning, and recruiting, payroll systems). This role serves as the primary liaison between IT, HRIS, and HR stakeholders, ensuring that HR applications align with enterprise architecture standards, IT compliance requirements, and business goals. The ideal candidate has hands-on Workday experience, a strong understanding of HR processes, and proven success in leading system enhancements, integrations, and IT data governance initiatives. **Key Responsibilities** Systems Management & Architecture + Serve as the technicallead for **Workday** and other HR-related applications. + Design andmaintainthe **HR systems architecture** , ensuring alignment with enterprise IT standards and data governance policies. + Oversee Workday configuration, testing, and deployment across modules (HCM, Absence, Compensation, Talent, Recruiting, Learning, and others). + Manage integrations between Workday and downstream systems such as SAP, Payroll, Finance, and Identity Management platforms. + Ensure stability, scalability, and continuous improvement of HR systems through proactive monitoring and optimization. + Design,monitor, and troubleshoot integrations between Workday and external systems (e.g., ERP, Finance, Payroll providers, Identity Management). Stakeholder Engagement + Partner with HR, IT, and Finance stakeholders to deliver high-impact HR technology solutions. + **Primary liaison** for WorkdayTechnicalsupport, helpdesk, and enhancement requests. + Provide functional guidance and mentorship to HRIS analysts or other team members. Data, Reporting & Compliance + Managedata governance, ensuring accuracy, consistency, and compliance with data privacy and audit requirements. + Develop andmaintainreports, dashboards, and analytics to support business decisions. + Support internal and external audits by ensuring proper system controls and documentation. **Education & Experience:** + Bachelor's degree in information systems, Computer Science, Human Resources, or Business Management (Master'sdegree preferred). + 7+ years of hands-on Workday and HR Applications IT experience + Strong understanding of HR business processes (Core HR, Recruiting, Performance, Learning, Compensation, and Payroll). + Proven success in project management, system upgrades, and cross-functional collaboration. + Experience integrating Workday with ERP (SAP), payroll, and identity management systems. + Workday Pro Certification(s) in one or more modules (HCM, Compensation, Reporting, Integrations) is preferred. + Experience with Workday Extend is desired. + Proficient in Workday Studio, EIB, and Report Writer. + Strong analytical and troubleshooting skills. + Deep understanding of security roles, data governance, and SOX/ GDPR compliance. + Strong problem-solving, documentation, and communication skills. The base salary range for this role is $110,452 to $138,065. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Territory Sales Manager - Specialty.** As our Territory Sales Manager - Specialty, you will have a unique opportunity to be the face of Sumitomo Pharma America (SMPA) to our customers. We reinforce a performance-based environment of ownership and accountability for our sales professionals by assigning each territory to one Territory Sales Manager. **Job Duties and Responsibilities** You will primarily be responsible for achieving and exceeding sales objectives and growing market share. Specifically, you'll: + Manage the **assigned territory.** + Establish deep and meaningful business relationships based on your clinical and market dynamic expertise. + Increase market share base by closing new business in both new and existing accounts prioritized on market potential. + Support your sales results with an exceptional level of clinical expertise and understanding of the evolving healthcare landscape, thoughtful planning, purposeful action, and utilization of your available resources in a compliant manner. + Assess and analyze product/competitor trends and market dynamics. + Collaborate and provide candid, constructive communication with team members. + Travel is required throughout the territory. Overnight stays may be required, including meetings which may extend over several days (on occasion may include weekends) and require work during evening hours and/or overnight stays. **Key Core Competencies** + Demonstrated success applying clinical expertise (product/competition/disease state), understanding of the healthcare landscape, and critical thinking. + Demonstrated success analyzing trends and market dynamics to provide sales strategy recommendations and insights based on data. + Demonstrated history of a strong work ethic and professional presence. + Demonstrated ability to ensure all administrative tasks (including call reporting, sample management, expense reports, training modules, business plans, etc.) are completed in a timely, accurate and compliant manner. + Demonstrated ability to consistently operate in a manner which demonstrates and instills trust and integrity. + Ability to effectively work in a fast-paced start up environment. + Ability to comply with customer institution access requirements. + Ability to drive a car and possess a valid and current driver's license. + Ability and willingness to travel overnight as needed (~20%). **Education and Experience** + Bachelor's degree in a related field required. + 5+ years of pharmaceutical sales experience is required and a demonstrated mastery of product and disease state knowledge. + A proven, consistent, and documented track record of top-ranked sales performance (ideally ranked in the top 25% of the nation) + Preferred Qualifications: + Experience working within Urology. + Experience with a pharmaceutical launch. + Knowledge of market access formulary positioning, including pull-through and push-through. **Preferred Qualifications:** + Experience working within Urology. + Experience with a pharmaceutical launch. + Knowledge of market access formulary positioning, including pull-through and push-through. **General Skills:** + Desire to be part of a rapidly evolving organization where you will showcase your decision-making, leadership, collaboration, and problem-solving skills. + Passion to prove yourself as you develop, learn, and grow your knowledge, techniques, and skills. + Superior written and oral communication skills. + Proficiency with Microsoft Word, Excel, PowerPoint. + Excellent interpersonal and collaborative skills, and the ability to work independently and effectively in a highly dynamic environment. + Enthusiastic, driven, and able to adjust workload based on changing priorities. + Demonstrated planning and flexibility skills to work across a variety of projects to meet goals and complete work on time. **Value Competencies:** + Integrity and Compassion - Empathy, trustworthiness + Bold Innovation - Inclusive mindset + Achievement through Collaboration - Courageous communication The base salary range for this role is $113,600 to $142,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned programs(s). Ability to work collaboratively with cross-functional colleagues across the SMPA organization including, but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties and Responsibilities** + Work collaboratively with PV and cross-functional team members to manage the benefit/risk profile of assigned products and ensure patient safety. + Assist in signal detection activities including data assembly, signal validation, and signal evaluation. + Perform literature monitoring (with vendor support) and ensure appropriate sources are incorporated into signal detection activities. + Participate and lead aggregate safety report activities including data compilation and analysis as well as writing of assigned sections (with vendor support.) + Compile agenda, data, slides, and minutes in collaboration with Program Safety Lead for cross-functional Safety Management Team meetings. + Represent PV Operations on cross-functional program and project teams; support PV Medical Safety activities on cross-functional program and project teams, as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician, including communication with internal and cross-functional team members, submission of data requests, and compilation of analysis and results. + Contribute to internal departmental and/or cross-functional inspection readiness and operational improvement activities. + Collaborate with Clinical Development to interpret safety data from ongoing clinical trials. + Serve as a subject matter expert in Pharmacovigilance, including operations and medical, within the assigned program. + Support collaboration with external partners **Key Core Competencies** + Strong understanding of pharmacovigilance regulations and drug safety reporting requirements + Skills in signal detection, risk assessment, and safety data analysis + Proficiency with safety databases and software + Ability to evaluate and write case reports and prepare regulatory submissions + Analytical thinking and attention to detail + Communication skills for cross-functional collaboration and regulatory interactions + Project management and organizational abilities + Ability to work effectively within teams + Additionally, experience using tools such as Argus, Oracle, MedDRA, Empirica, and Excel is highly valuable for this position **Education and Experience** + Minimum of bachelor's level degree in a health care/life science related field, with Master's or other graduate degree preferred. + Minimum 3 years' experience within Pharmacovigilance and in the pharmaceutical industry. + Prior experience in oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and marketed products. The base salary range for this role is $127,920 to $159,900. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. **Key Responsibilities** + Responsible for overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. + Develop project specific TMF plan and structure and update the plan as needed. + Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as a liaison between the Site IRBs and study team to resolve queries and concerns. + Provide study team reports or updates regarding status of TMF on a regular basis. + Participate in audits and provide documents as requested. + Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. + Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health. **Professional Experience / Qualifications** + BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings + Knowledge of and direct experience with Trial Master Files. + Prior eTMF (e.g. Veeva) administration required. + Strong Microsoft Office skills required. + Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily function as a regional regulatory leader (RRL) and/or Global Regulatory Leader (GRL) for assigned products. This position is responsible for the preparation, coordination and monitoring of routine US and/or global regulatory submissions and responses to health authority (HA) information requests. In addition, this position may represent GRA in project related meetings, develop regulatory strategy and provide regulatory input as appropriate. This position works with a moderate level of independence and autonomy and requires some coaching and mentoring. **Job Duties and Responsibilities** + As a Regional Regulatory Lead, manage regional (United States, European and/or ROW) regulatory activities as part of a Global Regulatory Team (GRT) + As a part of the Global Regulatory Team (GRT), leads regulatory activities for assigned project(s) in line with the global registration strategy of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions with HAs + Supports and/or leads documentation of regulatory authority interactions including decisions and outcomes + Leads and coordinates project team members in developing strategy for applicable documents/ activities. + Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission + Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes and coordinate regulatory compliance activities at a global level + Provide updates to the Global Regulatory Team, project teams, and governance boards as needed + Maintains professional working relationships with colleagues, fostering collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contributes to content as needed + Advises team members of potential regulatory issues and provides possible solutions and mitigation strategy + Ensures the quality and content of all submissions to Health Authorities + Contributes to regional health authority meetings, and briefing book documentation to Health Authorities + Assist with development of the global regulatory functional plan through research, review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labeling + Responsible for creating and reviewing SOPs and regulatory department operating procedures, as needed. **Key Core Competencies** + Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills required + Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values + Ability to work in a diverse environment + Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization + Demonstrated ability to facilitate appropriate team decisions + Sense of urgency and perseverance to achieve results + Understanding of medical terminology, and FDA and ICH regulations/guidance documents specific to clinical research and general product development in the pharmaceutical industry + Experience reviewing nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contribute to content as needed + Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution + Contribution to the development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document + Ability to make complex decisions and willingness to defend difficult positions. + Comfortable presenting to all levels of the organization including Senior Management. **Education and Experience** + Bachelor's degree in a related field required, preferably in a scientific discipline. + At least 7 years of experience, prior biopharmaceutical or pharmaceutical industry experience; Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience preferred + Experience contributing to electronic regulatory submissions and working with regulatory templates + Understanding of EU Clinical Trial Regulation and ROW country regulatory requirements related to clinical trials The base salary range for this role is $156,000 to $195,000 . Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Duties and Responsibilities** + Support development of communications with Senior Executives and strategic partners to report analytical findings and key performance metrics + Develop models to set pricing strategy with the goal of supporting attainment of coverage goals and maximizing net revenue + Develop payer & provider deal models to assess the implications of deal scenarios on gross-to-net revenue and support development of business cases for review & approval by the Pricing Committee + Develop & refine gross-to-net models to support reporting and forecasting of short and long-range discount rates for Finance and the brand teams + Collaborate with the Market Access team on contract changes and amendments + Support roll-out of contracts to field staff + Review internal data/reports to ensure compliance with government pricing programs + Provide issue resolution and presentation of solutions from contract disputes + Support government price reporting and state price transparency reporting requirements **Key Core Competencies** + Experience in pharmaceutical secondary analytics and financial modeling + Understanding of Commercial and Medicare Part D pharmacy benefit designs + Understanding of gross-to-net and ROI calculations + Ability to prioritize and manage multiple tasks/assignments and meeting short deadlines + Interest in exploring and developing new approaches, processes and methodologies + Experience evaluating PBM/payer contracts to ensure they support Market Access objectives + Highly-skilled in influencing and effectively partnering with cross-functional teams + Excellent interpersonal, oral and written communication skills, project management, and confident executive presence + High level of proficiency with Microsoft Excel and PowerPoint + High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture **Education and Experience** + Bachelor of Arts or Science in Health Sciences or related discipline; MBA preferred + Minimum 15 - 20 years (without Master's) or 10 - 15 (with Master's) of relevant experience in biotech or pharmaceutical industry + 5-7 years' experience in data analysis, financial modeling, and decision support + Preference towards previous experience with product level forecasting The base salary range for this role is $183,360 to $229,200. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. The Senior Manager is a strategic leader responsible for overseeing Pharmacovigilance (PVRM) and non-PVRM vendor management, adverse event handling and reporting, and supporting global PV systems. This role oversees compliance training, quality monitoring, audit and inspection preparedness, and cross-functional initiatives to ensure operational excellence and regulatory adherence. The Senior Manager works closely with the PVRM Information Management (IM) and Safety Science groups and is a member of a cross-functional working team as part of a matrix team supporting PV activities. **Job Duties and Responsibilities** + Lead strategic relationships with PVRM and non-PVRM vendors, ensuring contract compliance, quality performance, and alignment with business objectives. + Provide strategic oversight of adverse event (AE) management and reporting processes, ensuring compliance with global regulatory requirements. + Conduct routine AE case quality checks, support special projects, and collaborate within PVRM and Quality on root cause analysis, corrective and preventive actions, effectiveness checks, and process improvements. + Lead audit and inspection preparedness, participate in cross-functional teams, and support regulatory inspections and internal audits. + Develop and maintain PV staff learning plans, manage compliance activities, and serve as the primary liaison for organized data collection and reconciliation of safety information. + Oversee the development, maintenance, and continuous improvement of standard operating procedures (SOPs) across PV operations and quality systems to ensure consistency, regulatory compliance, and operational excellence. + Support global safety planning and coordination, and maintain relationships with business partners, affiliates, and subsidiaries. + Provide expert support for Pharmacovigilance Agreements (PVAs), including but not limited to drafting, reviewing, and maintaining PVAs with internal and external partners. Support Alliance Management to ensure PVAs are compliant with global regulatory requirements and support the implementation and oversight of PVA obligations across the organization. + Contribute to standard operating procedures relevant to pharmacovigilance + Mentor and coach team members, foster a high-performance culture, and deliver results in a dynamic, fast-paced environment. + Assist with other department activities as needed. **Key Core Competencies** + Works effectively with minimal supervision. + High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture. + Self-motivated with solid management skills, and the ability to lead or participate effectively in cross-functional teams. + Skilled mentoring and coaching to develop team deliverables. + Proficient verbal and written communication skills. + Proficient in MS Office applications and adaptable to technology and systems. + Knowledge of current US and international pharmacovigilance regulations. + Ability to multi-task under limited direction and on own initiative. + Excellent interpersonal, written and verbal communication skills. + Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required. + Must have excellent customer-service orientation, high degree of professionalism, and ability to work with independently. + Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company. **Education and Experience** + Bachelor's degree required. Preferably in a scientific, regulatory, or health-related field; advanced degree preferred. + Minimum 8 - 10 years of relevant experience in healthcare industry. + Minimum 5 years of experience specific to Pharmacovigilance operations and compliance. + Project leadership/management skills. + Excellent understanding of U.S. regulations and guidances, and a strong working knowledge of global regulations and guidances, e.g., European Economic Area, United Kingdom, and Canadian regulatory frameworks. The base salary range for this role is $155,000 to $193,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** Lead IT compliance and governance programs in a regulated pharmaceutical environment. Ensure adherence to global regulations (GxP, FDA, EMA), manage IT risk, and oversee Business Continuity and Disaster Recovery. Partner with QA, Regulatory, and IT teams to maintain secure, compliant, audit-ready systems. **Job Duties and Responsibilities** + **Regulatory Compliance & GxP Oversight** + Ensure IT systems supporting GxP processes comply with FDA 21 CFR Part 11, EU Annex 11, and other applicable regulations. + Maintain IT compliance documentation including validation protocols, SOPs, and audit trails. + Oversee periodic IT compliance assessments and manage remediation plans. + Ensure ongoing compliance with ISO 27001 by supporting the ISMS framework, monitoring control effectiveness, and coordinating evidence and documentation for certification and surveillance audits + **Governance & Risk Management** + Develop and maintain IT governance frameworks aligned with pharmaceutical industry standards and corporate policies. + Conduct IT risk assessments for systems supporting clinical, manufacturing, and commercial operations. + Implement risk mitigation strategies and maintain risk registers. + **Business Continuity & Disaster Recovery (BC/DR)** + Own and manage the enterprise BC/DR program for IT systems. + Develop, maintain, and test disaster recovery plans to ensure resilience and rapid recovery of critical systems. + Coordinate with business units to align continuity strategies with operational priorities. + Ensure compliance with regulatory expectations for BC/DR in pharmaceutical environments. + **Audit & Inspection Readiness** + Serve as the primary IT contact for internal audits, regulatory inspections, and third-party assessments. + Ensure timely resolution of audit findings and continuous improvement of compliance posture. + **Policy & Standards Development** + Establish IT policies and standards for data integrity, cybersecurity, system lifecycle management, and BC/DR. + Ensure consistent application of governance principles across GxP and non-GxP systems. + **Training & Awareness** + Develop and deliver IT compliance and BC/DR training programs for system owners and end-users. + Promote a culture of compliance and resilience across IT and business teams. + **Cross-Functional Collaboration** + Partner with Quality, Regulatory, Clinical, and Manufacturing teams to ensure IT solutions meet compliance and continuity requirements. + Provide guidance on regulatory impacts for new technologies and digital initiatives. **Qualifications** + **Education:** Bachelor's degree in Information Technology, Computer Science, or related field; advanced degree preferred. + **Experience:** + 8+ years in IT compliance, governance, or risk management within a pharmaceutical or life sciences environment. + Strong knowledge of GxP, FDA 21 CFR Part 11, EU Annex 11, and global regulatory frameworks. + Proven experience managing audits, inspections, and BC/DR programs in a regulated industry. **Key Core Competencies** + Deep understanding of IT systems validation, data integrity principles, cybersecurity controls, and BC/DR best practices. + Excellent communication and stakeholder management skills. + Ability to influence and lead cross-functional teams **Preferred Certifications:** + CISA, CRISC, CGEIT + ITIL Foundation + GAMP 5 knowledge or certification + CBCP (Certified Business Continuity Professional) or equivalent The base salary range for this role is $152,000 to $190,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_