- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic ... and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This...hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc ... member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are currently recruiting for a Director , Global Marketing for Women's Cancer for the oncology portfolio.- The Global Marketing Director will ... as: target product profile development, global regulatory filing strategy, labeling , launch readiness reviews, organized customer interactions, market research,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... responses to Health Authority)Participant and voting member in the labeling development process in the Labeling Working...in the labeling development process in the Labeling Working Team (LWT), in collaboration with the CDLContributes… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs, PMAs and labeling for drug and diagnostic products. Provides guidance on planning, writing, review ... of key dossier documents for submissions globally. Ensure high quality collaboration with Clinical Biomarker and Companion Diagnostics team for development of biomarker, companion diagnostic and other device to optimize access to patients.Remains on the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... to Health Authority)- Participant and voting member in the labeling development process in the Labeling Working...in the labeling development process in the Labeling Working Team (LWT), in collaboration with the CDL-… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Medical Director serves as the subject matter expert for our products and related data within a ... Key Opinion Leaders (KOLs), Healthcare Professionals (HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical Director in the… more
- Genmab (Woodbridge, NJ)
- …with preparation and submissions of IND, (s)NDA/BLA to US FDA Experience with labeling and PMC/PMR negotiations with US FDA Ability to work well within ... cross-functional teams Strong communication skills - both oral and written Ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans Ability to influence others and resolve conflicts Cultural… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, NJ facility for an experienced MD to serve as Senior Director or Director , Clinical Development. Title and salary commensurate with ... issues related to development compounds or marketed products including labeling discussions/updates; Provides medical insight to draft responses to regulatory… more
- Careerbuilder-US (Rahway, NJ)
- …the US pharma products registrations and providing CVM/FDA support for labeling and chemistry, manufacturing, and controls (CMC) submissions. . The specialist ... product reports to the regulatory authorities; maintains US state registrations, labeling , drug listings; the registration database; and the veterinary compendium;… more
- J&J Family of Companies (Raritan, NJ)
- Associate Director , Global Labeling Product Leader (1 of 2) - 2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an Associate ... Director Global Labeling Product Leader (1 of 2) in Raritan, NJ; Titusville, NJ; Horsham, PA; Toronto, Ontario (CA); UK (High Wycombe); Netherlands (Leiden);… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic ... and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This...hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization ... acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product information and labeling … more
- Bausch Health (Bridgewater, NJ)
- …in the review, approval and monitoring of prescription drug advertising and promotional labeling pieces. The Director is responsible for ensuring the pieces are ... your skills and values drive our collective progress and impact. The Director of Advertising and Promotion, Prescription Drug Products manages and/or participates… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …promotional information, materials, and activities to ensure consistency with product labeling and with all applicable regulations. TheSenior Director , ... real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs, is responsible for the development and execution… more
- Bausch Health (Bridgewater, NJ)
- …and values drive our collective progress and impact. The Associate Director , Advertising and Promotion, Prescription Drug Products, reviews, approves and monitors ... prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements. Responsibilities **:** + Provides… more
- Novo Nordisk (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Medical Director serves as the subject matter expert for our products and related data within a ... Key Opinion Leaders (KOLs), Healthcare Professionals (HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical Director in the… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs** + Location: Cambridge, MA or Bridgewater, NJ **About the job** The ... Associate Director , US Advertising and Promotion serves as the regulatory...review committee (RC) by providing regulatory guidance on promotional labeling and advertising materials. + Develop solutions to complex… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- Job Title Senior Director , Clinical Development & Medical Affairs (CDMA) Requisition JR000014103 Senior Director , Clinical Development & Medical Affairs (CDMA) ... - USA501 Additional Locations Bridgewater, NJ Job Description The Senior Director , Clinical Development Medical Affairs (CDMA) drives strategy and accountability for… more
- AbbVie (Newark, NJ)
- …LinkedIn. Job Description *Position can sit remotely anywhere in the US The Director , Patient Centered Outcomes Research, is responsible for the design and execution ... functions (eg, Clinical Development & Operations, Regulatory, Commercial). The Director , Patient-Centered Outcomes Research, will support a therapeutic area and… more
