- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for the global ... on the project team throughout the product lifecycle. Provide senior staff advice and guidance on regulatory ...Salary Transparency Language:The base salary range for the Executive Director , Global Regulatory Affairs -… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel: Ability ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Novo Nordisk Inc. (WA)
- …colleagues locally and globally. Relationships Reports to the Market Access and Public Affairs Senior Director , Policy. Other internal relationships include ... About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare...in Plainsboro, NJ or Washington, DC. The Position The Director - US Tax, Trade, IP works on complex… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/Associate Director , has primary responsibility for ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Principal Scientist/ Director , Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes ... Global Medical and Scientific Affairs as well as Outcomes Research, and will support...and will support Pneumococcal Vaccines.Under the guidance of a senior leader, this position supports value evidence outcomes research… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole Summary Under the guidance of an Executive Director , has primary responsibility for developing value evidence strategies, and planning/managing ... incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates and may… more
- Merck & Co. (North Wales, PA)
- …role will focus on supporting HPV. Under the guidance of an Executive Director , within the Value and Implementation, Outcomes Research the incumbent has the ... of patient reported outcomes, epidemiological studies and economic modeling.The Director also works closely with Product Development Teams, Franchise Teams,… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning and execution ... of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include… more
- Genmab (NJ)
- …various regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director , ... like a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for… more
- Merck & Co. (Upper Gwynedd, PA)
- …integrating state-of-the-art technology and applying rigorous scientific and ethical standards.The Senior Director has primary responsibility for the planning ... development (pre-clinical to post-licensure). With a focus on late-stage development, the Senior Director will manage the entire cycle of clinical development,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensure consistency with brand/therapy area vision and message. Relationships Reports to Senior Director of Cardio Renal Marketing Responsible for providing ... affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , and other relevant NNI departments to ensure alignment ... pull you in? Are you ready to experiment with us? The Position The Director , Consumer Marketing, will be a pivotal driver in shaping an insights-driven consumer… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …other functional teams in NNI (including MAPA), including marketing, medical, R&D, regulatory affairs , finance, NNGlobal, and other relevant entities to develop ... design pull you in? Are you ready to experiment with us? The Position The Director Channel Strategy & Planning will play a critical role in shaping the future… more
- BioSpace (Tarrytown, NY)
- …with minimal guidance from the Regulatory Affairs , Advertising and Promotion Director . The Senior Manager Regulatory Affairs , Advertising and ... Details The Senior Manager position within the Regulatory Affairs department requires the ability to...advertising and promotion perspective with minimal guidance from the Regulatory Affairs , Advertising & Promotion Director… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The Senior Manager Health Care Professional Marketing will be responsible for supporting the development ... in alignment with overall business objectives. Relationships Reports to the Director of HCP/KOL Marketing. Collaborates with sales, marketing, training, and finance… more
- Leica Biosystems (Miami, FL)
- …make an impact.Learn about the Danaher Business System which makes everything possible.The Senior Principal, Regulatory Affairs is responsible for ... and digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will...excellence in the Biopharma sector.This position reports to the Director , Regulatory Affairs and is… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Finance, Customer Call Center, Enterprise Insights, Supply Chain, Procurement, Public Affairs , Public Policy, Regulatory , Legal, IT, Trade, Patient Safety ... reporting requirements and operational assessments. Relationships Reports to the Director , Patient Support Transformation and Enablement. Works closely with Market… more
- National Rural Electric Cooperative Association (Arlington, VA)
- …and Health Administration (OSHA), and the Federal Motor Carrier Administration (FMCSA). The Regulatory Affairs Director , Emergency Management and Safety is ... strategies that protect their interests. In addition to leading a regulatory portfolio, the role includes an emergency management coordinating function between… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. JOB SUMMARY The Senior Director , Head Medical affairs Quality Assurance in Global ... RWE Epidemiology Legal and compliance Marketing/ commercial GMP QA/ Supply chain / Regulatory Affairs Leadership/ team management: Create a high performing team… more
