- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory ... Global Process Lead actively engages with leadership across the Global Regulatory Affairs and Clinical Safety organization and collaborates with internal and… more
- 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
- Merck & Co. (Rahway, NJ)
- …guidance on labeling to teams.As the regulatory labeling liaison on global Regulatory Affairs subteams, your input will be essential to our operations.You ... labeling experience or relevant pharmaceutical industry experience (eg, Medical Affairs , Regulatory Affairs , Clinical, Pharmacovigilance).Current Employees… 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)
- …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
- 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)
- …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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …access, commercial insights and analytics, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... Managers, and Market Access), Brand Marketing, Training, Market Access & Public Affairs , Trade, Legal, Compliance, Finance, HEOR, and Market Research. The position… more
- Merck & Co. (Rahway, NJ)
- …of interest.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing to ... 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
- 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 ... message. This is a global job level 9. Relationships Reports to Brand Lead or Consumer Strategy Lead . Collaborates with cross-functional and global Alzheimer's… 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 ... pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Clinical Director May Be… 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
- Merck (Rahway, NJ)
- **Job Description** The Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory ... Global Process Lead actively engages with leadership across the Global Regulatory Affairs and Clinical Safety organization and collaborates with internal and… 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
- AbbVie (New York, NY)
- …medical affairs sponsored or supported clinical research activities. May lead cross functional teams in development and execution of strategic initiatives ... provides specialist medical/scientific strategic and operational input into core medical affairs activities within the designated therapeutic area. This will include… more
