- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director / Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for ... and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional… more
- Eisai, Inc (NJ)
- …difference. If this is your profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical affairs ... key business processes. Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and Commercial… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Associate Director , Global Medical Affairs will provide medical leadership for medical affairs ... supportive tactics for Oncology. Under the direction of the Senior /Executive Medical Director , this role will be...Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs… more
- Astellas (Westborough, MA)
- …Associate II, Analytical Development Senior Project Manager, Technical Operations Senior CMC Regulatory Affairs Manager, Cell/Gene Therapy Manager ... CMC Regulatory Affairs , Gene Therapy Associate Director CMC Regulatory Affairs , Gene Therapy Developing innovative therapies is one of the most… more
- Merck & Co. (Rahway, NJ)
- …execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be Responsible For:Evaluating pre-clinical and ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has...closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive ... working with key stakeholders to develop and execute the medical affairs plan, including data generations (including RWE), post-marketing research, medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …access, commercial insights and analytics, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... Compliance, Finance, HEOR, and Market Research. The position has high exposure to senior management and requires a highly motivated individual who is able to work… more
- Merck & Co. (Rahway, NJ)
- …- Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... entire cycle of clinical development,-including-study design, placement, monitoring, analysis, regulatory reporting, and publication.-- - Specifically, the Director… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and study protocols.This position independently manages relationships with internal (CSPV, Regulatory , Clinical, Medical Affairs , HEOR and other stakeholders to ... centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, and analytic support… more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Director May Be… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with external vendors and to contribute to study logistical conductance; with Regulatory Affairs to align study with health authority requirements; with ... design, and conductance of early development clinical studies; the preparation of regulatory documents to file IND and report studies; and the representation of… more
- Lundbeck (WA)
- …opportunity - Open to candidates anywhere in the greater United StatesSUMMARY:The Senior Manager, State Policy and Strategy position is responsible for serving as ... related to the state policy environment and collaborating with Government Affairs and cross-functional partners to ensure patient access to therapies, optimize… more
- Merck & Co. (Rahway, NJ)
- …studies;Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be… more
- Novo Nordisk Inc. (Stamford, CT)
- …coordination with his/er Field Director . Relationships Position reports to Field Director / Senior Field Director . Serves as organization spokesperson on ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...to make a difference? Willing to hire at the Senior ML level commensurate with experience. The Position Builds… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Regulatory Affairs CMC , Innovative Medicine (Hybrid) Date: Feb 28, 2024 Location: West Chester, United States, Pennsylvania, 19380 ... a difference, and new people to make a difference with. **The opportunity** The Senior Director , Regulatory Affairs CMC is responsible to manage and help… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Regulatory Affairs II Date: Mar 22, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job ... a difference, and new people to make a difference with. **The opportunity** The Senior Director , Regulatory Affairs II will have a knowledge of global… more
- Medtronic (Lafayette, CO)
- …need to own your future success. Together, we can transform healthcare. The Senior Director of Regulatory Affairs will lead the Regulatory team for ... be required. This role reports to the Vice President, Regulatory Affairs for the Surgical Operating Unit... staff and coach to ensure continuing development of regulatory skills + Keep Senior Management informed… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs , is responsible for the development and ... marketed products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs , in collaboration with Head, Regulatory … more
- Lilly (Indianapolis, IN)
- …new medicines to patients who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC will leverage CMC technical ... for people around the world. Lilly is looking for regulatory Chemistry Manufacturing Control (CMC) scientists to join us...knowledge and regulatory science expertise to drive regulatory CMC… more