- Genmab (Plainsboro, NJ)
- …information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy ... and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading… more
- Genmab (Plainsboro, NJ)
- … Affairs Solid Tumors Strategy will report to the Senior Director, US Medical Affairs Solid Tumors Strategy Lead . S/he will provide medical affairs ... US healthcare market through collaboration with US Commercialization, Global Medical Affairs , Clinical Development, Regulatory , and other cross functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other...disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaborations within and across line functions, eg Clinical Development, Medical Affairs , Regulatory Affairs , Clinical Operations. Formulates strategic ... with key high-level internal and external stakeholders and approves regulatory reports/submissions using expert safety knowledge.This position independently… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product ... Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of...for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… more
- Merck & Co. (Rahway, NJ)
- …with a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs . Facilitate operational meetings with CROs, License ... Responsible for development and maintenance of a PVA repository Lead development of contract templates in cooperation with Legal...and international PV regulations. Act as a subject matter expert in regulatory intel for PV and… 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 ... pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical Director May… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. 30% overnight ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Position The Medical Director serves as the subject matter expert for our products and related data within a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Access and Public Affairs (MAPA), Portfolio Strategy, Commercial Excellence, Regulatory Affairs , and other relevant NNI departments to ensure alignment ... embark on shaping our future. The Position The Rare Bleeding Therapeutic Area Lead is instrumental in shaping and executing NNI's strategic direction and initiatives… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... experiment with us? The Position The HCP - Strategy Lead (MASH) lead will be a pivotal...life cycle activities Health Systems strategy: Collaborates with medical affairs and market access teams to inform a health… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sales, marketing, medical affairs , market access and policy/advocacy (MAPA), regulatory affairs , and other relevant NNI departments to ensure alignment ... in? Are you ready to experiment with us? The Position The Brand Strategy Lead is pivotal in developing brand level objectives and strategic priorities. They will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... cross functional teams. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment...and science-driven global safety expert who would lead the ongoing assessment of safety profile of assigned… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …coordination of data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report and continued process verification ... to close nonconformance records and identify necessary corrections.Key Responsibilities Lead cross functional investigations independently from end to end. Ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … understanding of the pharmaceutical industry including marketing, medical, access, public affairs , compliance, legal and regulatory as well as the healthcare ... and new product commercialization assets (3 years prior to launch). They will lead the development and implementation of brand plans, development of capabilities to… 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 ... a consistent brand/therapy area vision and message. Relationships Reports to Brand Lead or Consumer Strategy Lead . Collaborates with cross-functional teams,… more
- dsm-firmenich (Princeton, NJ)
- ** Lead Expert Regulatory Affairs Pet Food** **Location: Plainsboro, NJ** **Hybrid** Are you a junior Regulatory Affairs professional ready to ... in this niche space where you can learn and grow. We are hiring a Lead Expert Regulatory Affairs Pet Food to support our Taste Texture and Health (TTH)… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT)...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Taiho Oncology (Princeton, NJ)
- …such as: Clinical Development, Commercial, Evidence and Value Development, Market Access and Regulatory Affairs to ensure, as needed, alignment and inputs + ... assigned indications. Position Summary: The Sr. Medical Director, Medical Affairs (SMD, MA) needs to be an expert...clear understanding of all areas and functions within medical affairs and able to lead strategic development… more
- AbbVie (Florham Park, NJ)
- …and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/provider interactions (HCPs, Patients and ... activities (promotional material generation/product launches) and market access. Drives Medical Affairs input into and influences the development of asset strategy.… more
