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Novo Nordisk jobs in Lexington, MA - 603 jobs

  • Senior ML Scientist - Molecular AI

    Novo Nordisk 4.9company rating

    Novo Nordisk job in Lexington, MA

    About the Site Our Research & Development organization brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown, and Cambridge reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients. About the Department The Molecular AI (MolAI) team is part of Novo Nordisk's AI and Digital Innovation (ADI) area where we apply and develop state of the art capabilities in predictive science, AI/ML and structure-based drug design. Scientists within MolAI collaborate seamlessly with teams across the globe to invent better molecules faster. With an unbiased approach to drug modalities, in-house access to the newest screening techniques, and world-class experimentation, we have a wealth of opportunities to impact our pipeline and ultimately save and improve patient lives. We work in multidisciplinary, highly collaborative discovery teams both locally and across Novo Nordisk's global network to invent novel medicines by applying advanced computational techniques and developing innovative computational methods. We engage in external collaborations to ensure access to cutting edge research and technology. We believe in the value of a diverse and inclusive culture. Together, we build and grow talent to ensure the development of new solutions. The team is comprised of collaborative, diverse and passionate people who have a true sense of pride in their work. We are committed to helping each other grow, and we are driven by the opportunity to make a difference in the lives of people living with chronic disease. Everything we do starts and ends with the patient. And, while changing the future of chronic disease treatment, such as diabetes and obesity, is no easy task, we also recognize the importance of an enjoyable workplace, which is why we've cultivated a culture of fun, ingenuity, and innovation. Our competitive compensation package and support of a healthy work-life balance all add to a best-in-class employee experience. The Position open to hiring at the Lead level commensurate with experience The Sr. ML Scientist - Molecular AI will be a critical team member of MolAI and contribute to the research team's effort towards exploring and creating new technology and continuing to be a world leader in molecular drug design. The Sr. ML Scientist will contribute to the development and deployment of state-of-the-art generative AI methodologies within computational drug design and contribute to the teams visibility in this field both internally and externally, via strong contributions to the research portfolio, cross-organizational engagement, presentations and publications. You will join a team and organization that is investing heavily in AI-enabled discovery: significant experimental and data-generation resources are being directed toward producing the high-quality datasets that make advanced generative models and other AI methods most effective. In this environment you will have the opportunity to develop and deploy state-of-the-art models that directly inform experimental design and accelerate therapeutic discovery. Relationships The Sr. ML Scientist - Molecular AI reports to the Head of Molecular AI and interacts closely with colleagues in the department and in the other departments within AI and Digital Innovation (ADI), in particular the area of Digital Chemistry and Design, to drive the applications of generative AI within R&D's computational drug discovery portfolio. Additional internal partners include experimental and data scientists, specialists, engineers, software developers, technology scouts & partnership developers and others across US and Denmark. External relationships include commercial and academic collaboration partners. Essential Functions + Scientific work + Support and drive integration of state-of-the-art generative AI methodologies within computational drug design + Optimize generative AI methodologies in conjunction with one or more design criteria for novel compound generation. + Develop and implement new deep learning methods + Execute training, fine-tuning and inference of large models on GPUs + Deliver state of art methodologies and capabilities to the design and optimization of therapeutics by applying and developing the latest machine learning and AI algorithms + Work with ML scientists and engineers to guide the development of our ML models + Conceptualize approaches, identify capability gaps, and set goals within molecular AI. + Represent AI and Digital Innovation as a technical/scientific lead on cross-functional research teams that include discovery, development and research IT organizations + Maintain a well-documented, reusable codebase, and traceable model history + Publish research in developing AI methods (example in ICLR, NeurIPS, ICML, Nature, Science, Cell etc.) + Collaborative teamwork + Work closely with experimental scientists, Digital Chemistry and Design, Research Engineer and other parts of the organization to driven the development and implementation of modern methods for molecular design + Actively participates in virtual global team meetings regularly + Participate in the evaluation of external and internal capabilities and facilitate collaborations with external partners + Present your results to an interdisciplinary team of experimental, modeling scientist and machine learning colleagues at company meetings and strategic program readouts Physical Requirements Up to 10% overnight travel required. Qualifications + Master's degree, or PhD is highly preferred. Minimum of a Bachelor's degree required. Degree within machine learning, computer science, computational chemistry or a related quantitative discipline preferred. + Master's Degree with 3+ years' relevant experience, or PhD with little to no experience, or a Bachelor's degree with 5+ years' relevant experience, can be considered + Relevant experience includes: + Experience with modern molecular design AI technology. + Experienced in developing and implementing new deep learning methods + Experienced in PyTorch, training, fine-tuning and inference of large models on GPUs + Strong proficiency in Python and experience with PyTorch deep learning libraries and HPC. + Knowledge of at least 2 of the following: deep learning, diffusion models, reinforcement or active learning, large language models related to the disciplines of molecular design + Excellent problem-solving skills and the ability to work independently as well as in a team environment. + Preferred experience includes: + Experience in pharmaceutical industry, healthcare industry, regulated medical device development or in another regulated field + Ability to execute own data science tasks while mentoring more junior Data Scientists in the development of their skills. + Excellent oral and written communication skills. + Detail oriented with strong documentation skills + Examples of your work, such as GitHub repository or publications that can showcase your skill We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger - a legacy of impact that reaches far beyond today. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at **************. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
    $83k-106k yearly est. 5d ago
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  • Senior Lead ML Scientist - Molecular AI

    Novo Nordisk 4.9company rating

    Novo Nordisk job in Lexington, MA

    About the Site Our Research & Development organization brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown, and Cambridge reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients. About the Department The Molecular AI (MolAI) team is part of Novo Nordisk's AI and Digital Innovation (ADI) area where we apply and develop state of the art capabilities in predictive science, AI/ML and structure-based drug design. Scientists within MolAI collaborate seamlessly with teams across the globe to invent better molecules faster. With an unbiased approach to drug modalities, in-house access to the newest screening techniques, and world-class experimentation, we have a wealth of opportunities to impact our pipeline and ultimately save and improve patient lives. We work in multidisciplinary, highly collaborative discovery teams both locally and across Novo Nordisk's global network to invent novel medicines by applying advanced computational techniques and developing innovative computational methods. We engage in external collaborations to ensure access to cutting edge research and technology. We believe in the value of a diverse and inclusive culture. Together, we build and grow talent to ensure the development of new solutions. The team is comprised of collaborative, diverse and passionate people who have a true sense of pride in their work. We are committed to helping each other grow, and we are driven by the opportunity to make a difference in the lives of people living with chronic disease. Everything we do starts and ends with the patient. And, while changing the future of chronic disease treatment, such as diabetes and obesity, is no easy task, we also recognize the importance of an enjoyable workplace, which is why we've cultivated a culture of fun, ingenuity, and innovation. Our competitive compensation package and support of a healthy work-life balance all add to a best-in-class employee experience. The Position - open to hiring at the Principal level commensurate with experience The Sr. Lead/Principal ML Scientist - Molecular AI will be a critical senior member of MolAI team. This is a senior, high-impact role within MolAI. You will work closely with the team to set scientific and technical direction for the team and to develop new AI-driven projects that influence R&D priorities across Novo Nordisk. You will be a visible technical champion for generative AI in molecular design, shaping strategy, mentoring colleagues, and driving cross-functional initiatives. You will join a team and organization that is investing heavily in AI-enabled discovery: significant experimental and data-generation resources are being directed toward producing the high-quality datasets that make advanced generative models and other AI methods most effective. In this environment you will have the opportunity to develop and deploy state-of-the-art models that directly inform experimental design and accelerate therapeutic discovery. Relationships The Sr. Lead/Principal ML Scientist - Molecular AI reports to the Head of Molecular AI and interacts closely with colleagues in the department and in the other departments within AI and Digital Innovation (ADI), in particular the area of Digital Chemistry and Design, to drive the applications of generative AI within R&D's computational drug discovery portfolio. Additional internal partners include experimental and data scientists, specialists, engineers, software developers, technology scouts & partnership developers and others across US and Denmark. External relationships include commercial and academic collaboration partners. Essential Functions + Provide senior scientific leadership: identify capability gaps, set goals, and lead initiatives that deliver business impact. + Lead research and development of generative AI methodologies for computational drug design; advance, optimize, and deploy models that balance multiple design criteria. + Translate computational insights into experimental strategies and leverage the organization's substantial data-generation capabilities to train and validate models. + Develop and implement new deep learning approaches (e.g., diffusion models, reinforcement/active learning, LLMs for molecular design) and maintain a well-documented, reusable codebase with traceable model history. + Represent MolAI externally and internally: publish in top venues, present at conferences, and build collaborations with academic and commercial partners. + Mentor and grow talent: lead, guide, and develop junior ML scientists and engineers; promote best practices in version control, CI/testing, and model reproducibility. + Participate in cross-functional teams and program readouts, partnering closely with Digital Chemistry and Design, experimental scientists, research engineers, and IT. + Publish research in developing AI methods (example in ICLR, NeurIPS, ICML, Nature, Science, Cell etc.) + Advise leadership in the formation of global teams of experts to address specialized tasks + Drive the implementation of data science best practices across Novo Nordisk + Demonstrates ability to drive frequent collaborations with external commercial and academic partners. Physical Requirements Up to 10% overnight travel required, including internationally Qualifications + M aster's degree or PhD highly preferred. Minimum of Bachelor's degree required. Degree within within machine learning, computer science, computational chemistry or a related quantitative discipline preferred . + Master's Degree with 8+ years' relevant experience, or PhD with 6+ years' relevant experience or a Bachelor's degree with 10+ years' relevant experience, can be considered + Relevant experience includes: + Strong track record with modern molecular design AI technologies and a demonstrated history of leadership and cross-disciplinary impact. + Deep proficiency in Python and PyTorch; experience training, fine-tuning and deploying large models on GPUs and HPC environments. + Experience with modern version control, CI/testing systems, and well-documented code practices. + Knowledge in at least two of: deep learning, diffusion models, reinforcement/active learning, LLMs in molecular design. + Demonstrated ability to translate computational work into experimental strategies and influence program decision-making. + Strong publication record or clear thought leadership in AI for biology/molecular design + Excellent communication, collaboration, and mentorship skills. + Detail oriented with strong documentation skills as demonstrated through examples from your GitHub repository or publications + Excellent written and oral communication skills; experience presenting technical results to diverse scientific audiences. + Demonstrated ability to generate valuable and relevant ideas, create concepts based on ideas, and develop new products based on concepts + Ability to set AI project metrics and drive activities to meet those metrics We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We're not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at **************. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
    $105k-135k yearly est. 8d ago
  • Head of Immunology Clinical Development

    Sanofi 4.3company rating

    Cambridge, MA job

    The Head of Immunology Clinical Development leads and mentors a large clinical team, driving the development of immunology therapies through strategic planning and collaboration across functions. This role involves oversight of clinical development plans, regulatory submissions, and prioritization of resources to advance drug candidates for immune-mediated diseases. The position requires extensive experience in clinical development, regulatory expertise, and strong leadership skills to manage complex projects and teams globally. Job Title: Head of Immunology Clinical Development Location: Cambridge, MA Morristown, NJ About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: Lead the clinical development organization within the immunology TA (over 50 physicians and scientists), supporting, mentoring and coaching the clinical development teams across indications and assets. Ensure appropriate resourcing of the clinical teams based on the TA priorities. Provide subject matter expertise to all clinical development deliverables as a senior clinical development expert in the TA, including clinical development plans, protocols, primary data read-outs, clinical study reports and primary publications. Be a key thought partner for excellence in clinical development in collaboration with other immunology TA functional heads, including statistics, safety, regulatory, translational medicine and research. Strategic Leadership: Support the teams developing and implementing the clinical development strategy for the Immunology TA, aligning with organizational goals and managing specific development plans for products and indications. Ensure appropriate alignment across assets as well as appropriate prioritization based on TA goals. Serve as a member of the TA leadership team, participating the success of the TA management and portfolio development and optimization. About You Qualifications: Education: MD or MD/PhD, specialization in an area relevant to Immunology development is preferred (eg pulmonary, allergy/immunology, dermatology, gastroenterology) Experience: 10+ years' experience in clinical development is preferred, with preference for development in immune-mediated diseases. Advantageous to have developed therapies across different immune-mediated indications and different sub-therapeutic areas. Preference for experience across different phases of development. Current or prior experience managing teams, with preference for prior experience managing larger teams. Significant regulatory experience, with preference for experience with global regulatory submissions. This position may require up to 25% overall travel An ideal candidate will Be passionate about coaching and mentoring Work collaboratively Be comfortable leading teams through complex development decisions and regulatory interactions Have strong fundamental knowledge of drug development Be able to make challenging portfolio trade-off decisions Prioritize and make challenging resourcing decisions Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or a lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA; #LI-SA; #LI-Hybrid; #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here. Keywords: immunology clinical development, clinical trial management, drug development leadership, immune-mediated diseases, clinical research strategy, regulatory submissions, team leadership healthcare, biopharmaceutical development, clinical protocols, medical affairs immunology
    $140k-211k yearly est. 6d ago
  • Global Head of mRNA Research & Biomarkers

    Sanofi 4.3company rating

    Waltham, MA job

    A global biopharmaceutical company is seeking a Global Head of Research and Biomarkers in Waltham, MA. This executive role involves leading R&D for mRNA and LNP, strategizing biomarker optimization, and managing teams of scientists. Ideal candidates will have a PhD and over 15 years of experience in the biotech industry, alongside skills in molecular biology and team leadership. This is an opportunity to advance next-gen scientific innovations in vaccines. #J-18808-Ljbffr
    $69k-97k yearly est. 1d ago
  • Quality Documents Expert

    Sanofi 4.3company rating

    Cambridge, MA job

    Job Title: Quality Documents Expert Location: Morristown, NJ Cambridge, MA About the Job Join the engine of Sanofi's mission - where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions. The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a cutting-age safety group, to enable us to optimize the benefit-risk of our therapies, so we can best serve our patients and consumers. The Quality Documents Expert is part of the Pharmacovigilance Quality (PVQ) department in PSPV function working in an international and culturally diverse team. The Quality Documents Expert participates to the robustness of the quality system by supporting the Quality Documentation. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities: * Supporting the Pharmacovigilance, Medical and Transversal Quality Operations (TQO) quality documentation (QD) and its related training * Promoting harmonization of quality standards * Communicating on processes and tools related to quality documentation Major duties and responsibilities: * Ensure the preparation and maintenance of Pharmacovigilance and Medical Quality documents (QDs) in line with global quality standards * Promote a single consistent approach in sanofi processes: * * Contribute to the establishment and monitoring of the annual QD plan. Ensure sanofi architecture of QDs is applied. * - Foster simplification and avoid redundancy of Quality Documents * Ensure timeliness and quality of Quality documents in the Content Management System (CMS): * * Ensure documents are following the correct workflow steps * - Perform a technical review of each document ensuring writing rules are followed * - Monitor workflow steps of each document until approval. Remind authors, reviewers and authorizer as needed. * - Communicate on the approval and effective dates of Quality Documents * Ensure the delivery of training of the concerned QDs by creating training link in the Learning Management Systems(s) and preparing e-learning material with SMEs * Lead or participate to specific projects related to process or tools improvements, assess impacts, set up and monitor action plans * Maintain up-to-date the documentation describing Quality Documents activities * Perform gap assessments on Global QDs and follow-up Corrective Actions and Preventive Actions (CAPA) plan * Provide guidances and support to countries on the management of their local QDs * Contribute to the preparation and communication of Quality Documents metrics and Key Performance Indicators (KPI) * Support inspections and audits by providing required data on due time, participating to interviews, contributing to Root Cause Analysis (RCA) and CAPA proposal * Collaborate with key stakeholders from Quality Document network About You About You Qualifications: * Bachelor's degree (Certified health professional degree e.g. Nursing, Pharmacist, Health Science degree) * 2+ years' experience in GxP Quality system management, Quality Documents or Medical/Scientific writing * 2+ years' experience in Pharmacovigilance and/or medical activities * Knowledge in International Pharmaceutical Regulation e.g. GVP, GCP, ICH * Advanced use of Microsoft Word and Excel * Advanced use of Content Management System (CMS) * Use and develop dashboards * Project Management skills Preferred: * Team player that cooperates transversally in a cross-functional environment * Analytic, proactive, and problem-solving mindset * Self-motivated, able to relentlessly prioritize, plan effectively and autonomously * Organized and detail oriented while seeing the big picture * Efficient time management * Customer focus Why Choose Us * Bring the miracles of science to life alongside a supportive, future-focused team. * Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. * Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. * Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Onsite #vhd Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $108,750.00 - $157,083.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
    $108.8k-157.1k yearly Auto-Apply 33d ago
  • Transformation Leader - External Manufacturing - Biologics

    Sanofi 4.3company rating

    Northborough, MA job

    Job Title: Transformation Leader - External Manufacturing - Biologics About the Job Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster. EM&S is leading the SANOFI CMO network and is committed to engage and manage external partners delivering exceptional manufacturing solutions. As we embark on a journey of growth and expansion, we are seeking a dynamic and experienced professional to lead our Business Transformation efforts in EM&S Spe Care. The Transformation Leader at the EM&S GBU level plays a key role in supporting transformation initiatives within the EM&S GBU. Acting as the primary link between the central transformation office and local EM&S GBU teams, the Transformation Leader ensures that projects are successfully adopted and embedded into daily operations. This role is focused on driving engagement, building change readiness, and ensuring that the transformation objectives deliver sustainable impact within the GBU. This positioning makes the Transformation Leader a “local transformation enabler”: ensuring alignment with global vision, while guaranteeing practical adoption and ownership in the GBU. **This is a hybrid role - 3 days a week onsite - required. ** About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities: Support Transformation Delivery Partner with the Global Transformation Leader to implement enterprise-wide programs within the GBU. Localize change strategies to fit the GBU context, culture, and priorities. Act as a key point of contact for all change-related activities in the GBU. Drive Adoption & Engagement Ensure employees and managers understand the why, what, and how of transformation initiatives. Develop and execute communication and training plans to maximize adoption. Monitor adoption and embed new behaviors, processes, and tools into the GBU. Stakeholder & Leadership Support Build strong relationships with GBU leaders to support them as change sponsors. Provide coaching and guidance to managers and teams to reinforce change behaviors. Act as a trusted advisor to GBU leadership on change readiness and risks. Change Measurement & Reporting Track change adoption KPIs and report progress to the Transformation Leader and GBU leadership. Identify resistance, barriers, and adoption gaps, and proactively recommend solutions. Capture lessons learned to continuously improve change implementation in the GBU. About You Bachelor's degree in Business, Human Resources, Organizational Development, or related field. 5+ years of experience in change management or organizational transformation. Strong knowledge of CMO/CDMO manufacturing - Required. Strong knowledge of change management frameworks Demonstrated ability to work in complex, matrixed organizations. Excellent communication, facilitation, and interpersonal skills. Proven track record in supporting digital, operational, or organizational transformation programs. Certification in Change Management or Project Management is a plus. Key Competencies of a Transformation Leader As a CMO Business Operations & Transformation Lead, here are the essential competencies that a transformation leader must master: Vision & Strategy Strategic thinking: Ability to see the "big picture" and anticipate trends Organizational alignment: Connect transformation to business objectives Change Management Change management: Master methodologies Resistance management: Identify and address barriers to change Change communication: Adapt messages to different audiences Operational Competencies Project/Program Management Business acumen with ability to translate transformation into operational impact. Problem-solving and analytical thinking. Process optimization: Identify and implement improvements Digital literacy: Understand emerging technologies (AI, automation, cloud) Innovation: Promote experimentation and learning Relational Competencies /Leadership & Influence Cross-functional work: Orchestrate multi-functional teams Inspirational leadership: Mobilize and engage teams Influence without authority: Convince stakeholders at all levels and relationship building at GBU level. Emotional intelligence: Understand and manage emotions during change change Negotiation: Find compromises and create consensus Soft Skills Communication: Strong communication and facilitation skills (Clarity, active listening, storytelling) Empathy: Understand the human impact of change Resilience and adaptability in dynamic environments. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Onsite #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $147,000.00 - $212,333.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
    $147k-212.3k yearly Auto-Apply 46d ago
  • PCP/Endo Business Specialist-Boston North

    Boehringer Ingelheim 4.6company rating

    Boston, MA job

    The PCP/Endo Business Specialist is responsible for developing and implementing a plan for maximizing net sales of BIPI and co-promoted diabetes products that aligns with direction from BIPI commercial leadership and with BIPI guidelines, policies, and directives. The PCP/Endo Business Specialist will conduct their business with key targeted healthcare providers and community hospitals, and may have additional responsibilities in teaching hospitals, federal and military hospitals, managed health care facilities, group purchasing organizations, integrated delivery networks, etc. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Compensation Data This position offers a base salary typically between ($95K) and ($153,100k). The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements. For an overview of our benefits please click here. Duties & Responsibilities Utilizes product knowledge and demonstrated selling skills in order to influence targeted health care professionals to support the use of BIPI promoted diabetes products. Executes brand strategies to ensure that company sales and marketing messages are delivered appropriately to customers. Establishes and maintains effective communication/cooperation/coordination with co-promotion partners and BIPI employees. Completes pre-call plans to meet key stakeholder needs. Builds discussion around customer needs and opportunities. Fosters customer network development and communication. Has accurate and timely follow-up discussions with customers. Fosters ongoing trust with customer as relationship develops. Uses appropriate BIPI Sales Training techniques to facilitate the customer decision making process. Coordinates the engagement of healthcare providers through a range of personal and non-personal channels, according to customer preferences. Identifies top plans for customers. Engages customers in comprehensive discussions on the payer environment, co-pays, and formulary access. Works with Managed Care Area Managers to generate and sustain support for products on MCO formularies. Develops and influences an extended team to pull-through MCO decisions. Delivers on "continuation of care" model, including discharge protocol, treatment algorithms, disease management, etc. Analyzes qualitative and quantitative territory information to optimize territory business plan and customer calls. Monitors local market conditions for changes that impact business. Develops plans to optimize allocation of key resources, including samples, co-pay cards, funds for speaker programs, and funds for in-office meals. Adjusts implementation plans on a regular basis (speaker mgmt., advocate development, etc.). Leverages opportunities that meet both territory and brand tactics. Utilizes supporting analysis tools to plan activity, report and monitor resource utilization, and maintain account and customer records. Completes all administrative responsibilities as directed by management. Successfully completes all Sales Training requirements. Identifies thought leaders, innovators and advocates to support BIPI products. Works with trained speakers for diabetes topics and products. Provides feedback and follow-up to speakers and attendees. Initiates contacts and network-building among advocates and customer groups. Develops plans to develop speakers and thought leaders. Manages programs and budgets to stay within standards. Works effectively with all customer-facing roles (i.e. Account teams, Medical teams, etc.) in a given geography to meet customer needs and deliver net sales objectives. Demonstrates strong collaboration and communication as customers evolve and ownership of accounts transition from traditional to account based. Performs all Company business in accordance with all regulations (e.g., EEO, FDA, DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIPI's excellent reputation within the medical and pharmaceutical community. PCP/Endo Business Specialist Requirements Bachelor's degree from an accredited institution is preferred. A minimum of two (2) years successful sales and/or marketing experience in pharmaceutical/healthcare industry, pharmacy, B2B, customer engagement services or equivalent Experience in diabetes therapeutic area preferred. History of successful performance Meets expectations for the key competencies required for this role Proficiency in Excel, Word, Outlook, and database applications Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate; exceptions to be granted by senior sales leadership. Valid Driver's License and an acceptable driving record Authorization and ability to drive a Company leased vehicle or authorized rental vehicle. Physical Demands / Surroundings Daily Travel within territory throughout the work day with multiple stops and visits to office buildings, hospitals and clinics. Going up and down stairs, bending, walking and lifting above head to shelf pharmaceutical material or goods. Periodic overnight travel for training and meetings. Intermittent repetitive lifting up to 40 lbs. Visual Demands Pass state motor vehicle vision requirement to operate motor vehicle. Must be able to work both with external and internal customers. Comfortable in new environments and adverse conditions. Temperaments/Mental Requirements Must be able to work with diverse groups of people in similar roles, interact with medical practitioners, business partners, manage stress and conflict associated with gaining access to physicians in a highly competitive environment. Level of Proficiency Must have the ability to learn and retain complex material, pass tests demonstrating product and disease-related knowledge and deliver content to physicians verbally in a clear, effective and accurate manner in strict compliance with regulatory and other requirements. Attendance / Schedule At least 40 hours per week, requires morning and evening flexibility as necessary to meet physician's schedules and coordinate evening speaker programs - Must be able to function in a self-directed work environment. Proficient in remote engagements with key customers via video conferencing platforms. Able to deliver clear and compliant sales presentations remotely using video, phone and digital media applications. Understands how to build customer relationships that facilitate live and virtual engagement opportunities. These physical and mental requirements represent a sampling of the physical / mental requirements considered essential to the position. Although this is an accurate representation, it is by no means complete and may be changed or updated as needed. It is an essential function of/minimum qualification for this position that the employee/applicant be eligible and authorized under all U.S. Export Laws (defined below): a) to be employed by the Company; and b) to receive any technology from the Company that may be required to perform the duties of this position or to which an applicant/employee may, by virtue of holding such position, be provided access by the Company or any third parties during the course of employment. “Export Laws” means the Export Administration Regulations (“EAR”) of the U.S. Commerce Department's Bureau of Industry and Security, presently at 15 CFR §§ 730-799, and the economic sanctions regulations of the U.S. Treasury Department's Office of Foreign Assets Control (OFAC), presently at 31CFR Chapter V, as they may be amended from time to time. Executive PCP/Endo Business Specialist Experience in diabetes therapeutic area preferred History of successful performance Meets expectations for the key competencies required for this role Proficiency in Excel, Word, Outlook, and database applications Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate; exceptions to be granted by senior sales leadership. Valid Driver's License and an acceptable driving record Authorization and ability to drive a Company leased vehicle or authorized rental vehicle. Physical Demands / Surroundings Daily Travel within territory throughout the work day with multiple stops and visits to office buildings, hospitals and clinics. Going up and down stairs, bending, walking and lifting above head to shelf pharmaceutical material or goods. Periodic overnight travel for training and meetings. Intermittent repetitive lifting up to 40 lbs. Visual Demands Pass state motor vehicle vision requirement to operate motor vehicle. Must be able to work both with external and internal customers. Comfortable in new environments and adverse conditions. Temperaments/Mental Requirements Must be able to work with diverse groups of people in similar roles, interact with medical practitioners, business partners, manage stress and conflict associated with gaining access to physicians in a highly competitive environment. Level of Proficiency Must have the ability to learn and retain complex material, pass tests demonstrating product and disease-related knowledge and deliver content to physicians verbally in a clear, effective and accurate manner in strict compliance with regulatory and other requirements. Attendance / Schedule At least 40 hours per week, requires morning and evening flexibility as necessary to meet physician's schedules and coordinate evening speaker programs - Must be able to function in a self-directed work environment. Proficient in remote engagements with key customers via video conferencing platforms. Able to deliver clear and compliant sales presentations remotely using video, phone and digital media applications. Understands how to build customer relationships that facilitate live and virtual engagement opportunities. These physical and mental requirements represent a sampling of the physical / mental requirements considered essential to the position. Although this is an accurate representation, it is by no means complete and may be changed or updated as needed. It is an essential function of/minimum qualification for this position that the employee/applicant be eligible and authorized under all U.S. Export Laws (defined below): a) to be employed by the Company; and b) to receive any technology from the Company that may be required to perform the duties of this position or to which an applicant/employee may, by virtue of holding such position, be provided access by the Company or any third parties during the course of employment. “Export Laws” means the Export Administration Regulations (“EAR”) of the U.S. Commerce Department's Bureau of Industry and Security, presently at 15 CFR §§ 730-799, and the economic sanctions regulations of the U.S. Treasury Department's Office of Foreign Assets Control (OFAC), presently at 31CFR Chapter V, as they may be amended from time to time
    $95k yearly 57d ago
  • Manager, Global Product Quality - Controlled Substances

    Otsuka America Pharmaceutical Inc. 4.9company rating

    Boston, MA job

    The Manager, Global Product Quality - Controlled Substances is responsible for ensuring that all activities related to controlled substances across the product lifecycle meet Good Manufacturing Practices (GMP) and comply with global regulatory requirements, including DEA regulations. This role partners closely with R&D, Supply Chain, Product Development, and Warehousing & Distribution teams to ensure robust quality oversight and regulatory compliance in the handling, storage, manufacturing, and distribution of controlled substances. The role may also support day to day quality oversight of clinical and commercial products to ensure they are manufactured, tested, packaged, stored and distributed in compliance with Current Good Manufacturing Practices (CGMP) regulations, Otsuka Quality Standards and US/global (if applicable) regulatory requirements. **Key Responsibilities** + Product Oversight: Provide GMP oversight and guidance during the drug development process including review and approval of documentation and collaboration and oversight of suppliers/contract manufacturers.Act as a liaison with regulatory agencies and internal compliance teams regarding controlled substance matters. + Quality & Compliance:Serve as the quality and compliance lead for controlled substances, ensuring adherence to DEA regulations and other global controlled substance requirements (e.g., Health Canada, EMA, ANVISA). Develop, implement, and maintain global SOPs and standards for the compliant handling, storage, transportation, and distribution of controlled substances. Ensure warehousing and distribution operations meet all applicable regulatory and internal quality requirements, including security, inventory reconciliation, and chain-of-custody controls. + Audit & Inspection Readiness: Support DEA inspections, audits, and regulatory submissions, ensuring readiness and robust documentation. Participates in regulatory inspections and audits as required. + Process Optimization: Oversee and enhance quality systems related to product quality complaints, CAPA, deviations, and change control for controlled substances. + Data Analysis & Reporting: Monitor and analyze compliance metrics and trends to identify risks and drive continuous improvement initiatives. + Cross-functional Collaboration: Collaborate with R&D, Supply Chain, Product Development, and Manufacturing to ensure quality and compliance are integrated throughout the lifecycle of controlled substance products. + Training & Documentation: Provide training and guidance to global teams on controlled substance regulations, GMP expectations, and best practices. Authors and maintains SOPs, Work practices and Job Aids, related to assigned quality activities. **Qualifications** Required + Bachelor's degree in Chemistry, Engineering, Life Sciences, or a related field. + Minimum 5 - 7 years of experience in a regulated industry (pharmaceutical or medical device), with 3-5 years in pharmaceutical quality, with specific experience in controlled substances and commercial quality operations. + Demonstrated expertise in DEA regulations and compliance, including registration, quota management, recordkeeping, and reporting. + Working knowledge and understanding of FDA/ICH/USP requirements, including FDA 21 CFR Parts 210, 211, and Part 11 (and Part 820, if applicable), ICH Q7 + Strong understanding of GMP requirements and global regulatory expectations for controlled substances. + Experience managing quality systems (e.g., deviations, CAPA, change control, complaints) in a regulated environment. + Proven experience in warehousing and distribution controls, including security, inventory management, and transportation compliance for controlled substances. + Excellent communication, collaboration, and project management skills. + Must be detail oriented and able to write and/or review Technical Documents + Ability to work effectively in a global, cross-functional, and matrixed environment Preferred Experience + Experience with electronic Quality Management Systems (eQMS) such as Veeva, TrackWise, or similar. + Certification in DEA compliance, Quality Assurance, or Regulatory Affairs. **Disclaimer** This is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $104,640.00 - Maximum $156,400.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
    $104.6k yearly 33d ago
  • Biostatistics Evidence Generation & Decision Sciences (EGDS)- Summer 2026 Intern

    Sanofi 4.3company rating

    Cambridge, MA job

    About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our B&P Neurology team as a Data Analyst and you'll lead one or several late phase studies, or lead an indication for a complex compound, under supervision of statistical project leader and/or team leader. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: * Contribute to the design and analysis of both early- and late-phase clinical trials by applying advanced statistical methods and data analysis techniques. * Support the development, evaluation, and implementation of innovative statistical methodologies to address complex problems in clinical research. * Work collaboratively under the guidance and mentorship of senior-level statisticians, gaining hands-on experience in study planning, data interpretation, and the preparation of statistical reports and publications. About You Basic Qualifications: * Currently enrolled and pursuing PhD in Statistics or Biostatistics at an accredited college or university * Candidates must have completed at least two years of graduate coursework and be working on a dissertation toward a PhD in Statistics or Biostatistics * Experience with SAS and R * Must be able to relocate to the office location and work 40hrs/week, Monday-Friday, for the full duration of the co-op/internship * Must be permanently authorized to work in the U.S. and not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually require future sponsorship for long term employment and do not meet the requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship Preferred Qualifications: * Effective oral and written communication skills * Experience with python is a plus Why Choose Us? * Bring the miracles of science to life alongside a supportive, future-focused team. * Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. * Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. * Exposure to cutting-edge technologies and research methodologies * Networking opportunities within Sanofi and the broader biotech community. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA #LI-Onsite #vhd Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
    $39k-46k yearly est. Auto-Apply 46d ago
  • Cardiometabolic Care Specialist - Ecosystem - Framingham Massachusetts

    Novo Nordisk 4.9company rating

    Novo Nordisk job in Framingham, MA

    About the Department The Cardiometabolic Care Sales Team is at the forefront of US sales efforts for Novo Nordisk's robust cardiometabolic product portfolio, which includes world-class therapies for treating multi-morbid conditions such as diabetes, obesity, and the reduction of major adverse cardiovascular events. Our ambition is to advance broad cardiometabolic disease management by bringing exciting new therapies to market to improve patient outcomes. As a team member, you will connect therapies to new specialties, build cardiometabolic advocates, and apply learnings that impact local markets and the organization in a cross-collaborative way. At Novo Nordisk, we create value by having a patient-centered approach and are committed to providing innovation to the benefit of our stakeholders. We focus on personal performance and development and have a culture centered on helping leaders create the conditions for people to be at their best. If you want to join a highly diverse and collaborative team and are ready to take the next step in your career with a company committed to meeting the evolving needs of patients with cardiometabolic diseases, come join us! The Position This role serves as the primary representative of Novo Nordisk within a specified geographic area, engaging with selected health systems, key academic centers, specialists, primary care providers, and other stakeholders. The primary objective is to optimize sales and establish Novo Nordisk as a frontrunner in the cardiometabolic care market. The Cardiometabolic Care Specialist I - Ecosystems is responsible for achieving sales targets by effectively promoting Novo Nordisk's product portfolio to healthcare providers and influencers involved in purchasing, prescribing, and formulary decisions. Additionally, this position assesses customer needs and recommends the most suitable Novo Nordisk products and services, ensuring adherence to approved guidelines. Relationships Externally, the CMCS I - Ecosystem I maintains relationships with physicians, pharmacists, nurses, and other key stakeholders within targeted accounts and community advocacy partners. The CMCS I - Ecosystem must work collaboratively with all stakeholders who influence business in the local market. Internally, the CMCS I -Ecosystem I reports to the Ecosystem Business Manager. The CMCS I -Ecosystem I also must work collaboratively work with all internal stakeholders. Essential Functions * Account Management * Assess and adapt sales and promotion strategies to align with health system account practices, care pathway decisions and managed care impact in the territory * Develop and update annual health system account plans to build lasting relationships and maximize sales outcomes * Cultivate relationships with specialists, key health system decision-makers, and stakeholders, leveraging internal resources to tailor value propositions and address specific needs * Overcome resistance to product prescribing within the health system context, utilizing tailored strategies and research-based account plans * Represent Novo Nordisk at academic institutions to influence residents and fellows, while tailoring selling strategies and establishing effective account routes for sales growth * Business Acumen * Engage broad set of stakeholders * Exhibit strong understanding of health systems and ability to discuss economics of hospital and/or group, including quality metrics, as needed * Ability to view, manipulate and extract actionable insights from data to build and execute a business plan * Manage and prioritize time and resources efficiently to attain maximum results in the sales territory with limited supervision * Manage time and tasks to achieve maximum customer effect and sales volume * Utilize discretionary budget for maximum impact on sales * Clinical Understanding * Deep understanding of cardiometabolic disease state and patient population * Identify differentiating profiles between competing products * Inform health system decision makers, influencers and stakeholders… hospital faculty, medical students, residents, interns as well as attending physicians, nurse practitioners and pharmacy personnel about the use of Novo Nordisk's portfolio of products for care of diabetes, including the approved uses and advantages of Novo Nordisk's products and services for their patients * Maintain knowledge of the most recent clinical studies to inform customers and address questions, concerns, and objections to the use of Novo Nordisk's products * Participate in company-sponsored and/or company-approved training programs to constantly improve knowledge of Novo Nordisk's products and competitive products * Understand how products address clinical needs * Selling Skills * Anticipate and respond to customers objections, problems, and concerns * Ask customer to commit to next actionable step on every call * Functions as a high-level contributor at meetings, conventions, training programs, and displays * Communicate activity in the territory by completing monthly reports and other reports as appropriate * Contribute to the company's sales goals * Describe and market Novo Nordisk's cardiometabolic product portfolio, emphasizing their features, benefits, imperatives, and which products are best suited for specific patient profiles or circumstances * Establish call continuum working with internal stakeholders regarding all relevant parties assigned to health system * Estimate the level of investment, time, human resources, and funds needed to achieve the maximum return * Facilitate as appropriate other field force customer engagement as needed * Identify, understand, and evaluate the needs of the targeted accounts and increase sales of Novo Nordisk's products by tailoring the approach for each call on each customer to achieve maximum results * Implement and manage special marketing and other programs and special projects * Notify field sales management of any/all account programs or initiatives that could directly or indirectly effect or impact field sales activity * Recommend sales and marketing strategies based on evaluation of customer needs, dynamics, trends, and competitors' products or services * Sell and promote Novo Nordisk's cardiometabolic portfolio and services with a focus on endocrinologists, primary care physicians, institutions, discharge planners and other key personnel who make or influence at the health system's prescribing decisions to include large scale presentations to external customers * Work with Ecosystem Manager to identify and anticipate potential trends, changes to health system conditions and areas of opportunity and incorporate into the district business plan * Work with Ecosystem Manager to most effectively leverage marketing materials and product information to sell and promote Novo Nordisk's products Physical Requirements Driver must maintain a valid driver's license. Must be in good standing by not exceeding the Novo Nordisk points threshold assigned based on review of Motor Vehicle Records. Qualifications * Bachelor's or equivalent degree, and/or Pharm D required * Minimum of one (1) year of experience working in one or more of the following areas preferred: Pharmaceutical/Healthcare, Sales, Consulting, Customer Service or Military * Demonstrated ability to drive sales in multiple business channels * Demonstrated leadership and decision-making ability * Expert knowledge of cardiometabolic disease state and Novo Nordisk's products is needed * Intermediate computer skills required (Windows Word and Excel); prior computer experience using sales data/call reporting software preferred * Must be a self-starter and be able to evaluate options and make decisions on your own with minimal supervision * Must maintain a valid driver's license Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process. This position is part of a job family. Title and level within the job family are evaluated based on a number of factors, such as years of experience, scope of work, proficiency, and business need. Candidates will be assessed for the most appropriate title and level within the job family during the recruitment process. The base range of pay for each title in this job family are as follows: * Cardiometabolic Care Specialist I - Ecosystems - $86,000 to $106,000 * Cardiometabolic Care Specialist II - Ecosystems - $113,000 to $138,000 * Senior Cardiometabolic Care Specialist - Ecosystems - $128,000 to $156,000 We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger - a legacy of impact that reaches far beyond today. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at **************. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
    $48k-74k yearly est. 4d ago
  • Director, Field Strategy & Operations (Everest)

    Otsuka America Pharmaceutical Inc. 4.9company rating

    Boston, MA job

    **About Otsuka** We defy limitation, so that others can too. In going above and beyond-under any circumstances-for patients, families, providers, and for each other. It's this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. **Position Overview:** The Director of Field Strategy and Operations serves as the orchestrator of field strategy, ensuring that prioritization, stakeholder engagement, and execution are effectively aligned with brand strategy and enterprise objectives. This role provides leadership across multiple regions, enabling a holistic, enterprise-wide approach to field strategy and operational excellence. This role also partners closely with the Business Analysis team to ensure field teams have access to standardized dashboards and data-driven insights, supporting execution excellence and performance tracking. The Director will be the point of contacts for ad hoc analytics requests, ensuring field teams have the right data to make informed decisions, but will not be creating these reports themselves or with their team and will work with Business Analysis to ensure accurate measurement and proper data is used. **Key Responsibilities:** + **Strategic Prioritization & Field Execution:** Align field activities with marketing strategy, launch planning, and market access pull-through, ensuring execution efficiency. + **Execution Excellence & Field Performance Tracking:** Oversee Omnichannel efforts, account planning, and KPI tracking, ensuring insights from Field Analytics support execution. + **Strategic prioritization & orchestrating field execution: Analyzes current and future state of the business based on insights and trends, and** leads efforts to align field activities with high-priority initiatives such as marketing strategy, launch planning, and market access pull-through. + **Field Communication & Data-Driven Decision Support:** Act as the primary field communicator, ensuring clarity on CRM tools, performance insights, and operational priorities. + **Resource Allocation & Budget Optimization:** Optimize the distribution of budgets, speaker programs, and promotional resources, leveraging data-driven insights to maximize ROI. + **Team Development & Analytics Training:** Mentor team members on business reviews, reporting systems, and analytics interpretation, working with Business Analysis to enhance field intelligence capabilities. + **Compliance Management:** Must comply with all state and federal laws, regulations and guidelines including PhRMA Code on Interactions with Healthcare Professionals as well as complying with all OAPI standards and policies relating to all job activities. **Qualifications:** + Bachelor's degree required; MBA or advanced degree preferred. + Minimum of 10 years of pharmaceutical experience, with a strong understanding of sales force operations and execution. + Prior experience in field leadership roles such as first- or second-line leadership, regional operational and customer strategy roles or other field-based support roles required. + Established expertise in business analytics, business operations, sales support, and resource management within a commercial pharmaceutical organization. + Ability to focus on priorities and resolve operational issues effectively. + Excellent communication and collaboration skills, with the ability to work cross-functionally and drive execution efficiency. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $194,247.00 - Maximum $290,375.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
    $194.2k yearly 60d+ ago
  • Associate Director, Biostatistics

    Otsuka America Pharmaceutical Inc. 4.9company rating

    Boston, MA job

    Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. As an Associate Director, Biostatistician, you will be a champion of Otsuka's culture and values and will be responsible for providing statistical expertise/input in the drug development including clinical development plan and regulatory submission strategy. This is a strategic and critical role in the development of protocols and statistical designs in different phases of the clinical trials leading to approval of drug products in different phases of the clinical trials. This position can be based in Princeton, New Jersey, or Rockville, Maryland. Remote arrangements can also be considered. Otsuka maintains a hybrid work policy and travel is expected 20% of the time based on business needs. You will report to the Senior Director, Biostatistics. **** + Provides statistical analysis plan, including study design, sample size, primary and secondary endpoints, and statistical analysis method in protocol development + As core study/project team member, provide statistical input in different perspective of the clinical trial conduct such as CRF review, IRT setting, DMC set up, annual reports and PSUR + Develops Statistical Analysis Plan (SAP) and mock TFLs for interim or final analyses + Participate strategic planning of regulatory interactions and Provides tables and listings for FDA meeting briefing packages. + Support statistical needs for market access and publications. + Core team of developing final study report (FSR), including authoring statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, FDA issues, and general drug development. + Reviews clinical, statistical, and regulatory literature for current clinical trial results, regulatory trends and new statistical methods to be applied on his/her assigned therapeutic area. + Attend FDA meetings, FDA advisory boards, or other scientific meetings. + Serves as the Biometrics Trial Lead (BTL) in the project team and provides expertise and input regarding the statistical analysis, TFLs format and data collection and quality, and overall timeline. + Provides technical supervision over other biostatisticians assigned to his/her therapeutic area and assigns them the statistical tasks. + Takes full responsibility in managing biostatistical tasks (as listed above) for one therapeutic area and provides strategic technical support to other clinical projects. + Provides technical direction to supporting statisticians working on projects on a day-to-day basis. **Qualifications/ Required** **Knowledge/ Experience and Skills:** + Understands the company's products, the competition, and the pharmaceutical industry in general. + Demonstrates a competent knowledge of the company's work tools, processes, and policies. + Maintains a current awareness of new drug developments and statistical methodologies in the business. + Requires a strong working knowledge of applicable U.S. regulatory requirements and NDA preparation for submissions. + Effective communications within biostatistics function and with study team and key stakeholders across different functional areas such as clinical, regulatory affairs, asset management, safety and clinical operation. + Familiar with regulatory submission process in US and EU. **Skills** + In-depth knowledge of statistical principles, applications, and SAS/R programming software. + Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). + Knows how/when to apply organizational policy or procedures to a variety of situations. **Educational Qualifications** + PhD or Master's degree in Statistics or Biostatistics. + Minimum 7 years (PhD) or 9 years (master degree) of experience in the pharmaceutical industry Experience in CNS area is a plus. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $164,530.00 - Maximum $245,985.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
    $164.5k yearly 59d ago
  • Director, Medical Publications - Neph & Immuno

    Otsuka America Pharmaceutical Inc. 4.9company rating

    Boston, MA job

    The Director, Nephrology & Immunology Publications Lead is responsible for leading the planning, development, and execution of the global medical publication strategy and publication deliverables for the Nephrology and Immunology therapeutic area. This role ensures the timely, accurate, and compliant communication of scientific and clinical data through congress abstracts, posters, manuscripts, and other peer-reviewed outputs. Serving as the functional lead for publication operations within the Nephrology & Immunology Medical Communications team, the Director partners closely with cross-functional stakeholders, including Clinical Development, Global Integrated Evidence & Innovation (GIE&I), Medical Strategy, Core Content, and external vendors, ensuring excellence and consistency in scientific communication across the portfolio. The position reports to the Senior Director, Nephrology & Immunology Medical Communications Lead and plays a key leadership role in advancing Otsuka's mission to deliver impactful, evidence-based science that improves patient outcomes. **** **Key Responsibilities Include:** **Publications Strategy and Execution** + Lead execution of the publication plans for Nephrology and Immunology assets, ensuring strategic alignment with global medical objectives, data dissemination priorities, and the product lifecycle + Partner with Medical Communications and cross-functional teams to define publication timelines, data priorities, and congress/journal strategies in collaboration with study teams and medical leaders + Oversee the end-to-end development of publication deliverables, including abstracts, posters, and manuscripts to ensure scientific accuracy, quality, and adherence to Good Publication Practices (GPP), ICMJE, and company SOPs + Support the integration of publication insights into broader scientific communication platforms (SCPs), ensuring consistency across core content, field materials, and other medical channels **Vendor & Budget Management** + Manage publication vendors and medical writing partners to ensure timely delivery, cost-effectiveness + Oversee operational management of external publication agencies, providing clear direction, review, and feedback to ensure alignment with scientific and compliance standards + Manage assigned publication budgets, including forecasting, tracking, and reconciliation + Ensure efficient resource utilization and drive continuous process improvement across publication workflows **Cross-functional Leadership** + Collaborate closely with Clinical Development, Global Integrated Evidence & Innovation, Medical Strategy, and Core Content teams to ensure data readiness, accurate interpretation, and timely publication of key clinical results + Serve as a publications subject matter expert within the Nephrology & Immunology Medical Communications function, providing strategic and operational guidance to internal stakeholders and vendors + Partner with Field Medical and Medical Information to ensure consistency of published data messaging across medical channels and external communications + Contribute to integrated medical communication planning, ensuring that publications effectively support data dissemination goals and launch readiness activities + Consider technology and AI to support workflow improvement **Compliance & Quality Oversight** + Ensure all publication activities are conducted in accordance with internal SOPs, GPP, ICMJE, and regional/global regulatory requirements + Partner with Legal, Regulatory, and Compliance teams to uphold publication governance, authorship transparency, and ethical data sharing standards + Contribute to audit readiness and documentation best practices for publication records and approvals **Qualifications** **Education and Experience:** + Advanced scientific or medical degree (PharmD, PhD, MD, or equivalent) required + 10+ years of experience in Medical Affairs, Medical Communications, or Publications within the pharmaceutical or biotechnology industry + Minimum 3-5 years of experience leading publication planning and execution for global or regional programs, preferably in Nephrology, Immunology, or related therapeutic areas + Proven experience managing vendors and external medical writers, including budget oversight and performance evaluation + Strong understanding of Good Publication Practices (GPP), ICMJE guidelines, and industry standards for scientific and medical communication **Skills and Competencies:** + Strong leadership presence and ability to present to executive leadership team + Demonstrated ability to lead publication strategy execution across global and regional teams + Exceptional project management and organizational skills, with the ability to manage multiple concurrent publication deliverables + Excellent written and verbal communication skills, with meticulous attention to scientific accuracy and compliance + Strong cross-functional collaboration skills, with the ability to influence and align internal and external partners + Proven leadership in vendor management, process optimization, and publication operations + Financial acumen and experience managing publication budgets + Strategic thinker with operational excellence mindset and the ability to translate complex data into clear, evidence-based scientific narratives **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $205,368.00 - Maximum $307,050.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
    $205.4k yearly 33d ago
  • Medical Science Liaison - Rare Diseases East

    Otsuka America Pharmaceutical Inc. 4.9company rating

    Boston, MA job

    **Customer Engagement Model** Otsuka America Pharmaceutical, Inc. has launched a new customer engagement approach designed to better deliver on patient, caregiver, and HCP needs in an evolving healthcare environment. The new model is built around where patients get their care-locally, with the intent to better serve patients, caregivers, and healthcare providers, delivering a higher quality experience that ultimately is focused on improving patient care. The local "ecosystem approach" creates a unified focus among account management, medical, patient access and market access to engage local healthcare systems and identify opportunities to improve the patient experience. Through this matrix model, customers will now experience more coordinated and seamless care with digital-enabled support to bridge care gaps. In Otsuka's evolved customer engagement model, a Health Science Associates (HSA) will engage HCPs through a variety of in-person, virtual and digital tools, offering expanded expertise regarding products and the approved conditions they treat. Otsuka's Clinical & Scientific Liaison (CSL) will provide deep clinical expertise on-demand and will engage healthcare providers to offer personalized education on disease state, thought leadership and real-world evidence. A Patient Education Liaison (PEL) works to inform, educate, and enhance the experience of patients throughout their care continuum. The HSAs are led by Ecosystem Leads and grouped into regional areas. Ecosystem Leads are led by Regional Leads with significant autonomy to assess unique market priorities and customize decisions that reflect local customer needs. In the future, Otsuka will also be shifting to a team-based approach to drive customer engagement quality, accountability, and cohesion around patients and healthcare providers. Ultimately, it is all about putting customers at the center of everything they do. **Position Overview** **- Medical** **Science Liaison** **(Senior Manager)** As an integral member of the ecosystem team for Otsuka's new ecosystem-based customer engagement model, the Medical Science Liaison (MSL), Sr Mgr contributes to the development of the ecosystem strategic business plan and identifies key stakeholders that are vital to the ecosystem. The Medical Science Liaison (MSL) is a credible partner responsible for providing clinical, scientific and health economic information related to disease states and the appropriate utilization of approved Otsuka products within an ecosystem. This field-based position will engage with Key Influencers (KIs), Local Practice Leaders (LPLs), healthcare providers, and patients' groups within their ecosystem, to further patient outcomes aligned with the overarching objectives of Otsuka. In collaboration with their ecosystem partners, CSLs contribute to the customization of the region business strategy to meet local ecosystem needs and are responsible for the medical and educational requirements of their customers. In addition, CSLs may be responsible for covering multiple products within a therapeutic area, as well as engaging in broad clinical and scientific discussions that impact patient care, resulting in rich customer insights shared within the ecosystem. **There are 2 positions available** **Key Activities and Responsibilities** + As part of the ecosystem team contributes a clinical and scientific perspective to the local execution plan that addresses ecosystem, and customer challenges, issues, and opportunities, to bring about improved patient care and outcomes. This extends to include coordination around execution of field activities. + Build, cultivate, and leverage external relationships with key scientific and medical customers and organizations within their ecosystem to ensure strong understanding of evolving healthcare trends, disease state, Otsuka products, systems, and services across the ecosystem landscape, including KIs, LPLs, Key Decision Makers (KDMs) and Patient Advocacy. + Maintain a comprehensive understanding of the ecosystem to ensure alignment with Otsuka's patient-centric strategy and priorities, including provision and delivery of optimal patient care. + To be a credible source of evidence-based information that demonstrates the value of Otsuka and its products from the clinical, economic, and humanistic standpoint and works in partnership with providers, payers, and other key stakeholders to apply practical real-world solutions to improve patient outcomes. + Build and cultivate important internal working relationships across the matrix team to ensure an enterprise approach when working with customers. Be accountable to regional Field Medical Affairs leadership to shape and execute on local medical strategies within planned timelines. + Actively contribute to planning, content development, and dissemination of disease state information to customers in the field on a regular basis using the remote customer engagement platform. + Disseminate disease state and healthcare landscape information to customers in the field on a regular basis utilizing remote customer engagement platform. + Responsible for delivering the training and evaluation of promotional and disease state speakers. + Serve as part of Otsuka's internal speaker bureau in support of product educational needs across the ecosystem. + Collect and submit medical insights that drive decision making and prioritization of evidence generation efforts and healthcare solutions, including sharing at the local ecosystem level. + Assist with Otsuka's clinical trials program, including registrational, post-marketing and Investigator-Sponsored Trials (ISTs), health economic outcomes research, other specific medical collaborations; provide clinical expertise and feedback regarding operational management of clinical trials to ensure optimal site selection and performance. + Support other areas of the organization including Safety & Pharmacovigilance for investigation of safety-related issues, Sales Training medical education on an ongoing basis including new hire and POAs, and the Field Medical Center of Excellence for mentoring and sharing of best practices. **Qualifications** + Advanced degree in Pharmacy, Medicine, Biological Sciences, Health Services Research or Public Health, (PharmD., M.D., PhD. or D.Ph.) is required. + Relevant therapeutic area knowledge is required. + Understanding of the interconnectivity of health systems, overall delivery of patient care and experience working with healthcare professionals and other decision makers. + Minimum of 3-5 years related work experience (clinical, health system or industry) + Outstanding business acumen; knows the industry, Otsuka's business model and value proposition, key competitors, and other marketplace factors/dynamics. Able to identify solutions with the overall goal of improved patient outcomes. + Excellent communication and collaboration skills; exhibits professional maturity, confidence, and competence. Strong conflict resolution skills: proven ability to achieve conflict resolution effectively and quickly with affected parties and work in a cross-functional environment. + Knows how to summarize and communicate complex information and business objectives in a concise and effective way during presentations and other interactions. + Understanding of industry legal, regulatory, and compliance landscape + Ability to work in an ambiguous environment undergoing transformation. + Demonstrates behaviors aligned with the Otsuka Corporate Brand including Perseverance, Unconventional Thinking, and Humility. + Business travel, by air or car, up to 70% of time depending upon size of ecosystem. + Preferred living location is key city in ecosystem. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
    $147k yearly 31d ago
  • Cardiometabolic Care Specialist - Hep/Gi - Boston Massachusetts

    Novo Nordisk 4.9company rating

    Novo Nordisk job in Boston, MA

    About the Department The Diabetes Sales Team leads the US sales efforts for Novo Nordisk's robust cardiometabolic product portfolio, which includes world class therapies for the treatment of diabetes, obesity, and the reduction of adverse cardiovascular events. As part of the team, you will have frontline exposure to our portfolio vision, business strategies, and critical market insights that drive our business forward. You will drive the NNI portfolio strategy in tandem with our marketing team, and balance performance with compassion to ensure that the latest therapies and products reach the people who need them most. At Novo Nordisk, we are the world leader in diabetes care and a major player in defeating other serious chronic conditions such as obesity, growth hormone-related disorders and rare bleeding disorders. We use our skills, dedication and ambition to help people with diabetes and other chronic or rare diseases. We are looking for individuals who want to do the same. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development. Are you ready to realize your potential? The Position Consistently achieves goals and maximizes sales by executing local Sales and Marketing strategies to promote Novo Nordisk products to HCPs (e.g. HEP/GI ) and key customers. Relationships Externally, the Specialty Field Sales Representative maintains relationships with physicians, pharmacists, nurses, and other key personnel in health care settings and major academic and large community health systems. The Specialty Field Sales Representative also assists their target physicians with their local clinical and educational initiatives by coordinating company resources (e.g., counterparts, materials, information, initiatives, etc.) to ensure an aligned approach to benefit improved patient health. Internally, the Specialty Field Sales Representative reports to the District Business Manager of the specific sales territory. The Specialty Field Sales Representative interacts on a regular basis with other field-based employees (e.g., DBMs, DCSs, Market Access Team, Diabetes Educators, Medical Liaisons) covering the same geographic areas. The Specialty Field Sales Representative actively shares information and plans to develop a common understanding of individual customers and overlapping market dynamics to ensure a coordinated approach. Essential Functions + Demonstrates competencies on a consistent basis with territory level impact + Drives sales, seeks wins, and drives outcomes to exceed goals + Collaborates at a high level by sharing key customer insights/trends with colleagues and stakeholders + Leads team/partner initiatives to consistently drive results based on understanding of hcp influence across total geography + Identifies and leverages key customer insights to remain ahead of market trends and developments + Consistently seeks wins and drives successful outcomes + Recognizes opportunities to productively and respectably challenge and influence target physicians' approach to patient management and adds value by sharing new information and unique insights + Leverages superior understanding of complexities within the targeted physician customer base in order to maximize performance + Applies high level business acumen and analytical skills to continually advance the business and drive exceptional results + Exhibits product and disease state fluency + Employs an account mindset by understanding the complexity and dynamics of the local market and adapt to business priorities (e.g. makes trade-offs to decide time spent in account vs. results) + Adapts and learns new skills to succeed in new environments; flexible to build upon what is available + Effectively develops and employs business and tailored account plans, employs keen business acumen and analysis, and utilizes developed tools and resources to address patient needs and meet sales goals and objectives + Demonstrates a keen ability to both think broadly across relevant stakeholders to ensure future success, as well as executing against immediate opportunities to drive performance + Coordinates and collaborates with other representatives to leverage provider relationships in both HCP settings to drive results across total geography + Executes sales strategies based on evaluation of customer needs, dynamics, trends, and competitors' products or services + Maintains required activity records/reports, including timely and accurate transmission of call data + Understand the scientific and clinical underpinnings of brand strategies and the implications and importance of generating advocacy and support for them + Demonstrates professionalism and a customer-focused approach with internal and external stakeholders by actively listening, identifying and addressing customers and patients' needs, and keeping commitments + Demonstrates proficiency in implementing the Novo Nordisk Way selling model with external customers and during company sponsored meetings: + Strategic Planning- Pre-Call Planning, Post-Call Analysis + Creates Customer Engagement-Open Purposefully, Uncover Needs + Adapts Approach-Provide Solutions and Deliver Core Messages, Resolve Objections + Call to Action-Gain Commitment with Impact, Transition + For launch of new products, programs and services, establishes alignment among targeted physicians around the need for change, the value propositions the new product, program or service represents and the appropriate patients that would benefit in order to ensure early trial and utilization + Generates advocacy for Novo Nordisk products and services by sharing approved clinical and scientific information and insights with target physicians + Recognizes opportunities to productively challenge HCPs clinical management of patients that respects their knowledge and experience and adds value by sharing new information and offering unique insights + Evaluates the patient and practice needs of customers utilizing a patient-centric approach and tailoring the approach to customers and patients' needs + Uses understanding of practice guidelines, chronic care models, protocols, etc. to engage HCPs in clinical conversations to appreciate how they manage patients with diabetes and where they currently position NNI products and devices + Exercises prudent control over samples and other company property in accordance with company policies and procedures and legal requirements + Manages discretionary territory budget and marketing promotional program budget to support territory sales goals + Demonstrates a broad understanding of the clinical treatment of diabetes and its comorbidities and complications by actively using approved resources to engage HCPs in constructive and ongoing dialogue to support improved patient health + Demonstrates thorough knowledge of all promoted NNI approved clinical studies and the skill to engage customers (prescribers, support staff, pharmacies) with fair balance on proper placement within the treatment continuum + Participates in and contributes product and disease state knowledge during sales and marketing meetings, training programs, conventions and displays as appropriate Physical Requirements Driver must maintain a valid driver's license. Must be in good standing by not exceeding the Novo Nordisk points threshold assigned based on review of Motor Vehicle Records. Qualifications + Bachelor's or equivalent degree, and/or Pharm D required + Minimum of two (2) years of relevant pharmaceutical, medical or healthcare experience required + Demonstrated leadership and decision-making ability + Ability to navigate PA's in rapidly developing market + Health Systems and/or Institutional Account experience is preferred + Clinical approach to selling and engaging customers + Intermediate computer skills required (Windows, Word, Excel); prior computer experience using sales data/call reporting software ideal + Knowledge of gastroenterology and/or hepatology experience is preferred + Must be a self-starter and be able to evaluate options and make decisions on your own with minimal supervision This position is part of a job family. Title and level within the job family are evaluated based on a number of factors, such as years of experience, scope of work, proficiency, and business need. Candidates will be assessed for the most appropriate title and level within the job family during the recruitment process. The base range of pay for each title in this job family are as follows: - Cardiometabolic Care Specialist, Hep/Gi I - $95,000 to $117,000 - Cardiometabolic Care Specialist, Hep/Gi II - $118,000 to $144,000 - Senior Cardiometabolic Care Specialist, Hep/Gi - $134,000 to $164,000 Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors. Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We're not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at **************. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
    $118k-144k yearly 60d+ ago
  • Director, Early Precision Medicine Regulatory Affairs

    Bristol Myers Squibb 4.6company rating

    Cambridge, MA job

    Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for biomarkers and diagnostics, focusing on early-stage development through proof of concept and supporting registrations. This role establishes scalable frameworks for investigational assay development, ensuring timely, compliant submissions that support patient stratification in Phase I/II studies. As a key member of the Translational Medicine CLIA Laboratory Steering Committee, the director drives coordinated early-stage drug-diagnostic strategies and health authority engagement to accelerate access to precision therapies. The position demands deep scientific and regulatory expertise (US, EU, Canada, PMD, TGA or Global Devices/IVD preferred), cross-functional leadership, and a commitment to innovation in early precision medicine. Key Responsibilities: * Drive the development and actively support the execution of innovative, compliant global regulatory strategies that enable cutting-edge biomarkers and diagnostic tests-enhancing the impact and value of our medicines across therapeutic areas. * Design and operationalize a scalable regulatory framework within BMS that supports both internal investigational assay development and clinical specimen testing, while overseeing external investigational use only assay development-ensuring strategic alignment with business needs and enabling timely, compliant submissions * Serve as the regulatory lead on the Translational Medicine CLIA Laboratory Steering Committee, providing strategic guidance and hands-on execution in the design, development, and testing of investigational use assays for patient selection and stratification in BMS Phase I/II studies-enabling business agility and advancing our commitment to precision medicine by ensuring the right drug reaches the right patient at the right time. * Champion innovative regulatory strategies to resolve complex challenges and accelerate patient access, while ensuring early integration of precision medicine approaches-including coordination of key regulatory and clinical documents to support drug and diagnostic submissions, proactive health authority engagement, and robust risk mitigation planning. * Cultivate inclusive, high-impact collaboration with Precision Medicine, Research teams, Global and Regional Regulatory Leads, Global Regulatory Operations, and Quality by delivering timely, strategic guidance in health authority engagements and policy review-ensuring diverse expertise is integrated to drive precision medicine innovation. * Oversee global precision medicine submissions and health authority interactions-including PSAs, SRD, Pre-subs, IDEs, including international related submissions for investigational use only assay in clinical studies-in partnership with the Precision Medicine Lead * Provide regulatory support on product partnership, vendor management and business development opportunities * Serve as a strategic regulatory thought leader by actively shaping policy through trade association engagement and maintaining deep awareness of scientific, competitive, and diagnostic industry trends-acting as a trusted resource for institutional knowledge and informing precision medicine decision-making across BMS. * Engages with stakeholders on a regular basis to better understand organization needs and risk areas and identify pragmatic impactful solutions Qualifications & Experience: * Degree Requirements: Solid scientific background, PhD., M.D., PharmD, MS * Significant experience in regulatory affairs and diagnostic-related development e.g., >8-10 years. * Scientific & Diagnostic Expertise: Deep expertise in global diagnostic development-including, but not limited to key markets such as US, EU, Canada, Australia, Japan, China submissions, etc.-with preferred subject matter proficiency in IHC, NGS, PCR, and/or mass spectrometry, spanning assay design through regulatory approval. * Biomarker & CDx Strategy: Extensive experience in designing regulatory strategies for companion diagnostics and biomarkers, with deep expertise in assay and IVD development-including analytical validation, clinical development, manufacturing, and global regulatory submissions through commercialization. * Regulatory Leadership & Strategic Planning: * Proven ability to lead teams through complex health authority interactions and issue resolution, paired with deep expertise in developing and executing global regulatory strategies across drug and device development. * Regulatory Standards Mastery, but not limited to GCP, GLP, CLIA, HIPAA, 21 CFR Parts 11, 312, 812, 820, ISO 13485, ISO 14971, EU IVDR, CMDR, TGA, PMDA, NMPA, and ICH guidelines to ensure compliance and quality across investigational use only assay programs. * Communication & Collaboration: Skilled in translating complex scientific and regulatory concepts into clear, actionable insights for senior leadership and cross-functional teams. Builds strong partnerships across internal and external stakeholders in matrixed environments to drive alignment and shared success. * Influence & Decision Making: Demonstrates high personal accountability and excels in facilitation, negotiation, and strategic influence. Proven ability to lead teams in making timely, high-quality regulatory decisions that balance innovation, compliance, and enterprise impact. * Inclusive Leadership & Continuous Improvement: Values diverse perspectives, fosters a culture of continuous improvement, and encourages open dialogue on risks, issues, and successes. * Travel: Up to 20% #LI-Hybrid If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Cambridge Crossing: $244,110 - $295,806 Princeton - NJ - US: $217,960 - $264,113 San Diego - CA - US: $240,460 - $291,377 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit ************************************* Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: * Health Coverage: Medical, pharmacy, dental, and vision care. * Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). * Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off * US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) * Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. * Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at ***************************************** Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at ********************. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1595190 : Director, Early Precision Medicine Regulatory Affairs
    $244.1k-295.8k yearly Auto-Apply 52d ago
  • NIGHT SHIFT: Specialist, Lead Manufacturing Associate, Cell Therapy in Devens, MA

    Bristol Myers Squibb 4.6company rating

    Devens, MA job

    Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team. BMS Cell Therapy Manufacturing seeks a Specialist, Lead Manufacturing Associate Cell Therapy that brings enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The candidate must be goal-oriented, flexible, and able to work efficiently with safety and quality in mind. We are searching for enthusiastic, and innovative individuals with a good understanding of good manufacturing practices to support routine manufacturing operations for Cell Therapy. Shifts Available: Night Shift (6pm - 6am) Rotational schedule including holidays and weekends, onsite Responsibilities: Execute operations described in standard operating procedures and batch records. Demonstrates strong practical and theoretical knowledge in their work. Completes documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. Solves complex problems; takes new perspectives using existing solutions. Performs tasks in a manner consistent with the safety policies, quality systems, and GMP requirements. Completing training assignments to ensure the necessary technical skills and knowledge. Sets up manufacturing areas and equipment/fixtures. Perform facility and equipment commissioning activities. Collaborates with support groups on recommendations and solving technical problems. Help to ensure the shift works effectively in a team based, cross-functional environment to complete all production tasks required by shift schedule. Collaborates closely with Shift Managers to ensure seamless pass down and communication of operational status. Supports investigations. Identifies innovative solutions. Supports writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements. Training others on SOPs, Work Instructions to successfully complete manufacturing operations. Working with production planning with leadership to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts. Work in a cleanroom environment and perform aseptic processing; maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements. Knowledge and Skills: Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. Must have the ability to work assigned shift (Day, Night, Weekends and/or Holidays). Must be able to work in a cleanroom environment and perform aseptic processing Must be comfortable being exposed to human blood components. Must be able to be in close proximity to strong magnets. Experience in cell therapy manufacturing, including Cell washing processes and automated equipment. Cell separation techniques and automated equipment. Cryopreservation processes and equipment. Experience in the following preferred: Aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human derived materials in BSL-2 containment areas. Cell expansion using incubators and single use bioreactors Basic Requirements: 4+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience Bachelors in relevant science or engineering discipline, or equivalent in work experience. Working Conditions: Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time, throughout the day. Carrying weight, Pushing, Pulling Lifting - Required to carry, lift, push, and/or pull up to 50 pounds several times a day while handling production equipment and/or materials. Climb - Required to climb (use of stepladders in production areas, or stairwells) several times a day. Bend and Kneel - Required to bend or kneel several times a day. Overhead work - Required to perform overhead reaching during handling of production materials/files/supplies up to 25 pounds several times a day, throughout the day. Moving Head and Neck - Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day, throughout the day. Twisting - Required movement of twisting waist while setting up equipment several times a day, throughout the day. Repetitive Use - Required repetitive use of arms/wrists/hands while setting up equipment and processing several times a day, throughout the day. Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection. BMSCART #LI-ONSITE GPS_2025 If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Devens - MA - US: $43.84 - $53.12per hour The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit ************************************* Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients' lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at ***************************************** Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at ********************. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1594619 : NIGHT SHIFT: Specialist, Lead Manufacturing Associate, Cell Therapy in Devens, MA
    $43.8-53.1 hourly Auto-Apply 60d+ ago
  • Director, External R&D

    Sanofi 4.3company rating

    Waltham, MA job

    Job Title: Director, External R&D About the Job The Director, External R&D (ER&D) will be responsible for sustaining Sanofi Vaccines' portfolio of new vaccines, vaccine candidates and vaccine technologies by identifying, evaluating and developing strategic partnerships with the global external network of public and private industry organizations. The position will report to and will work closely with the Global Head, External R&D, Vaccines R&D. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Main Responsibilities: * Proactively scan the external network of companies, academic institutions and government sponsored R&D organizations to identify and evaluate scientific and technological innovations relevant to the business of Sanofi Vaccines. * As a member of the ER&D team, develop and maintain the relationships with the vast network of external organizations through various platforms such as participating in partnering meetings and networking conferences, e.g., World Vaccine Congress, BIO, JPMorgan Healthcare, etc. * Provide a critical scientific and technical analyses of the external opportunities and collaborate with internal stakeholders (e.g., R&D, Medical Affairs, Franchise Strategy) to formulate the basis for recommendations on the external innovations. * Work closely with the Business Development and Legal teams to support business negotiations with potential external partners; provide scientific and technical input to support the constructive negotiations, accurate deal structure evaluations and appropriate deal structure; support the evaluation of the external party's confidential technical/due diligence materials by assembling the evaluation team, coordinating the interactions with the partner and contributing to the final technical due-diligence report. * Present to the Vaccines Leadership the outcomes of the assessments arising from the external company engagements to Vaccine Leadership as well as governance committees, including the External Innovation Evaluation Committee (EIEC), Therapeutic Area Review Committee (TARC), as appropriate. * Work collaboratively with internal stakeholders (R&D functions, mRNA Center of Excellence, Vaccine Portfolio Strategy, Vaccine Medical Affairs, Vaccine Public Franchise) to align the external engagement strategies with the needs and priorities of the organizations. * Work collaboratively with other teams within the External Scientific Affairs (ESA) organization to advance the mission of the ESA, including scouting for licensing/acquisitions, external funding, and vaccine innovation projects. About You Minimum Requirements: * M.D. or Ph.D. in bacteriology, virology, immunology, non-infectious disease, or other scientific discipline * 7+ years of post-graduate experience Skills & Capabilities: * Experience in Vaccines R&D and external partnering preferred * Demonstrated interpersonal skills - ability to work with individuals at different levels and managing through influence * Resourceful, entrepreneurial, and constantly up-to-date with vaccine-relevant innovation opportunities for Sanofi Vaccines * Demonstrated team and negotiation skills * Fluent English communication skills, verbal and written and ability to work in an international context * Up to 15% per year of domestic or international travel Why Choose Us? * Bring the miracles of science to life alongside a supportive, future-focused team. * Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. * Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. * Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP #LI-Onsite #vhd Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $178,500.00 - $257,833.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
    $178.5k-257.8k yearly Auto-Apply 11d ago
  • Quality Documents Expert

    Sanofi Group 4.3company rating

    Cambridge, MA job

    **Job Title:** Quality Documents Expert **About the Job** Join the engine of Sanofi's mission - where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions. The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a cutting-age safety group, to enable us to optimize the benefit-risk of our therapies, so we can best serve our patients and consumers. The Quality Documents Expert is part of the Pharmacovigilance Quality (PVQ) department in PSPV function working in an international and culturally diverse team. The Quality Documents Expert participates to the robustness of the quality system by supporting the Quality Documentation. **About Sanofi:** We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. **Main Responsibilities:** + Supporting the Pharmacovigilance, Medical and Transversal Quality Operations (TQO) quality documentation (QD) and its related training + Promoting harmonization of quality standards + Communicating on processes and tools related to quality documentation **Major duties and responsibilities:** + Ensure the preparation and maintenance of Pharmacovigilance and Medical Quality documents (QDs) in line with global quality standards + Promote a single consistent approach in sanofi processes: + - Contribute to the establishment and monitoring of the annual QD plan. Ensure sanofi architecture of QDs is applied. + - Foster simplification and avoid redundancy of Quality Documents + Ensure timeliness and quality of Quality documents in the Content Management System (CMS): + - Ensure documents are following the correct workflow steps + - Perform a technical review of each document ensuring writing rules are followed + - Monitor workflow steps of each document until approval. Remind authors, reviewers and authorizer as needed. + - Communicate on the approval and effective dates of Quality Documents + Ensure the delivery of training of the concerned QDs by creating training link in the Learning Management Systems(s) and preparing e-learning material with SMEs + Lead or participate to specific projects related to process or tools improvements, assess impacts, set up and monitor action plans + Maintain up-to-date the documentation describing Quality Documents activities + Perform gap assessments on Global QDs and follow-up Corrective Actions and Preventive Actions (CAPA) plan + Provide guidances and support to countries on the management of their local QDs + Contribute to the preparation and communication of Quality Documents metrics and Key Performance Indicators (KPI) + Support inspections and audits by providing required data on due time, participating to interviews, contributing to Root Cause Analysis (RCA) and CAPA proposal + Collaborate with key stakeholders from Quality Document network **About You** **About You** **Qualifications:** + Bachelor's degree (Certified health professional degree e.g. Nursing, Pharmacist, Health Science degree) + 2+ years' experience in GxP Quality system management, Quality Documents or Medical/Scientific writing + 2+ years' experience in Pharmacovigilance and/or medical activities + Knowledge in International Pharmaceutical Regulation e.g. GVP, GCP, ICH + Advanced use of Microsoft Word and Excel + Advanced use of Content Management System (CMS) + Use and develop dashboards + Project Management skills **Preferred:** + Team player that cooperates transversally in a cross-functional environment + Analytic, proactive, and problem-solving mindset + Self-motivated, able to relentlessly prioritize, plan effectively and autonomously + Organized and detail oriented while seeing the big picture + Efficient time management + Customer focus **Why Choose Us** + Bring the miracles of science to life alongside a supportive, future-focused team. + Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. + Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. + Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. \#GD-SG \#LI-GZ \#LI-Onsite \#vhd **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. _North America Applicants Only_ The salary range for this position is: $108,750.00 - $157,083.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (********************************************************************************************************* . Global Terms & Conditions and Data Privacy Statement (*************************************************************** Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (***************************** As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************
    $108.8k-157.1k yearly 32d ago
  • PCP/Endo Business Specialist-Boston North

    Boehringer Ingelheim 4.6company rating

    Boston, MA job

    The PCP/Endo Business Specialist is responsible for developing and implementing a plan for maximizing net sales of BIPI and co-promoted diabetes products that aligns with direction from BIPI commercial leadership and with BIPI guidelines, policies, and directives. The PCP/Endo Business Specialist will conduct their business with key targeted healthcare providers and community hospitals, and may have additional responsibilities in teaching hospitals, federal and military hospitals, managed health care facilities, group purchasing organizations, integrated delivery networks, etc. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. **Compensation Data** This position offers a base salary typically between ($95K) and ($153,100k). The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements. For an overview of our benefits please click here. (***************************************************************** **Duties & Responsibilities** + Utilizes product knowledge and demonstrated selling skills in order to influence targeted health care professionals to support the use of BIPI promoted diabetes products. Executes brand strategies to ensure that company sales and marketing messages are delivered appropriately to customers. Establishes and maintains effective communication/cooperation/coordination with co-promotion partners and BIPI employees. + Completes pre-call plans to meet key stakeholder needs. Builds discussion around customer needs and opportunities. Fosters customer network development and communication. Has accurate and timely follow-up discussions with customers. Fosters ongoing trust with customer as relationship develops. Uses appropriate BIPI Sales Training techniques to facilitate the customer decision making process. Coordinates the engagement of healthcare providers through a range of personal and non-personal channels, according to customer preferences. + Identifies top plans for customers. Engages customers in comprehensive discussions on the payer environment, co-pays, and formulary access. Works with Managed Care Area Managers to generate and sustain support for products on MCO formularies. Develops and influences an extended team to pull-through MCO decisions. Delivers on "continuation of care" model, including discharge protocol, treatment algorithms, disease management, etc. + Analyzes qualitative and quantitative territory information to optimize territory business plan and customer calls. Monitors local market conditions for changes that impact business. Develops plans to optimize allocation of key resources, including samples, co-pay cards, funds for speaker programs, and funds for in-office meals. Adjusts implementation plans on a regular basis (speaker mgmt., advocate development, etc.). Leverages opportunities that meet both territory and brand tactics. Utilizes supporting analysis tools to plan activity, report and monitor resource utilization, and maintain account and customer records. Completes all administrative responsibilities as directed by management. Successfully completes all Sales Training requirements. + Identifies thought leaders, innovators and advocates to support BIPI products. Works with trained speakers for diabetes topics and products. Provides feedback and follow-up to speakers and attendees. Initiates contacts and network-building among advocates and customer groups. Develops plans to develop speakers and thought leaders. Manages programs and budgets to stay within standards. + Works effectively with all customer-facing roles (i.e. Account teams, Medical teams, etc.) in a given geography to meet customer needs and deliver net sales objectives. Demonstrates strong collaboration and communication as customers evolve and ownership of accounts transition from traditional to account based. + Performs all Company business in accordance with all regulations (e.g., EEO, FDA, DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIPI's excellent reputation within the medical and pharmaceutical community. **PCP/Endo Business Specialist Requirements** Bachelor's degree from an accredited institution is preferred. A minimum of two (2) years successful sales and/or marketing experience in pharmaceutical/healthcare industry, pharmacy, B2B, customer engagement services or equivalent Experience in diabetes therapeutic area preferred. History of successful performance Meets expectations for the key competencies required for this role Proficiency in Excel, Word, Outlook, and database applications Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate; exceptions to be granted by senior sales leadership. Valid Driver's License and an acceptable driving record Authorization and ability to drive a Company leased vehicle or authorized rental vehicle. Physical Demands / Surroundings Daily Travel within territory throughout the work day with multiple stops and visits to office buildings, hospitals and clinics. Going up and down stairs, bending, walking and lifting above head to shelf pharmaceutical material or goods. Periodic overnight travel for training and meetings. Intermittent repetitive lifting up to 40 lbs. Visual Demands Pass state motor vehicle vision requirement to operate motor vehicle. Must be able to work both with external and internal customers. Comfortable in new environments and adverse conditions. Temperaments/Mental Requirements Must be able to work with diverse groups of people in similar roles, interact with medical practitioners, business partners, manage stress and conflict associated with gaining access to physicians in a highly competitive environment. Level of Proficiency Must have the ability to learn and retain complex material, pass tests demonstrating product and disease-related knowledge and deliver content to physicians verbally in a clear, effective and accurate manner in strict compliance with regulatory and other requirements. Attendance / Schedule At least 40 hours per week, requires morning and evening flexibility as necessary to meet physician's schedules and coordinate evening speaker programs - Must be able to function in a self-directed work environment. Proficient in remote engagements with key customers via video conferencing platforms. Able to deliver clear and compliant sales presentations remotely using video, phone and digital media applications. Understands how to build customer relationships that facilitate live and virtual engagement opportunities. These physical and mental requirements represent a sampling of the physical / mental requirements considered essential to the position. Although this is an accurate representation, it is by no means complete and may be changed or updated as needed. It is an essential function of/minimum qualification for this position that the employee/applicant be eligible and authorized under all U.S. Export Laws (defined below): a) to be employed by the Company; and b) to receive any technology from the Company that may be required to perform the duties of this position or to which an applicant/employee may, by virtue of holding such position, be provided access by the Company or any third parties during the course of employment. "Export Laws" means the Export Administration Regulations ("EAR") of the U.S. Commerce Department's Bureau of Industry and Security, presently at 15 CFR §§ 730-799, and the economic sanctions regulations of the U.S. Treasury Department's Office of Foreign Assets Control (OFAC), presently at 31CFR Chapter V, as they may be amended from time to time. **Executive PCP/Endo Business Specialist** Experience in diabetes therapeutic area preferred History of successful performance Meets expectations for the key competencies required for this role Proficiency in Excel, Word, Outlook, and database applications Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate; exceptions to be granted by senior sales leadership. Valid Driver's License and an acceptable driving record Authorization and ability to drive a Company leased vehicle or authorized rental vehicle. Physical Demands / Surroundings Daily Travel within territory throughout the work day with multiple stops and visits to office buildings, hospitals and clinics. Going up and down stairs, bending, walking and lifting above head to shelf pharmaceutical material or goods. Periodic overnight travel for training and meetings. Intermittent repetitive lifting up to 40 lbs. Visual Demands Pass state motor vehicle vision requirement to operate motor vehicle. Must be able to work both with external and internal customers. Comfortable in new environments and adverse conditions. Temperaments/Mental Requirements Must be able to work with diverse groups of people in similar roles, interact with medical practitioners, business partners, manage stress and conflict associated with gaining access to physicians in a highly competitive environment. Level of Proficiency Must have the ability to learn and retain complex material, pass tests demonstrating product and disease-related knowledge and deliver content to physicians verbally in a clear, effective and accurate manner in strict compliance with regulatory and other requirements. Attendance / Schedule At least 40 hours per week, requires morning and evening flexibility as necessary to meet physician's schedules and coordinate evening speaker programs - Must be able to function in a self-directed work environment. Proficient in remote engagements with key customers via video conferencing platforms. Able to deliver clear and compliant sales presentations remotely using video, phone and digital media applications. Understands how to build customer relationships that facilitate live and virtual engagement opportunities. These physical and mental requirements represent a sampling of the physical / mental requirements considered essential to the position. Although this is an accurate representation, it is by no means complete and may be changed or updated as needed. It is an essential function of/minimum qualification for this position that the employee/applicant be eligible and authorized under all U.S. Export Laws (defined below): a) to be employed by the Company; and b) to receive any technology from the Company that may be required to perform the duties of this position or to which an applicant/employee may, by virtue of holding such position, be provided access by the Company or any third parties during the course of employment. "Export Laws" means the Export Administration Regulations ("EAR") of the U.S. Commerce Department's Bureau of Industry and Security, presently at 15 CFR §§ 730-799, and the economic sanctions regulations of the U.S. Treasury Department's Office of Foreign Assets Control (OFAC), presently at 31CFR Chapter V, as they may be amended from time to time All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
    $95k yearly 60d+ ago

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