- 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)
- …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
- J&J Family of Companies (Titusville, 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… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be ... responsible for the development and implementation of labeling content and strategy of multiple assigned products in various stages of drug development, which may… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead where you will be responsible ... international standards and guidelines. You will provide strategic and tactical labeling expertise to teams while ensuring compliance with applicable regulatory… more
- Ascendis Pharma (Princeton, NJ)
- The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling activities across programs and stages of development, with ... States and the Americas and supporting global needs as required. The RA Associate Director , Labeling will be overall responsible for ensuring compliance with… 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
- Takeda Pharmaceuticals (Trenton, NJ)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be ... responsible for the development and implementation of labeling content and strategy of assigned product(s) in various stages of drug development, which may include… more
- Bausch Health (Bridgewater, NJ)
- …mission of improving people's lives with our health care products. 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… 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...review committee (RC) by providing regulatory guidance on promotional labeling and advertising materials. + Develop solutions to complex… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs** + Location: Bridgewater, NJ or Cambridge, MA **About the job** The ... Associate Director , US Advertising and Promotion serves...AdPromo input to the development of optimal FDA product labeling on original and supplemental New Drug Applications and/or… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , PV Sciences Pleasanton, CA, USA * Princeton, NJ, USA Req #361 Monday, April 22, 2024 Looking for a chance to make a meaningful difference in ... on a transformative journey with Taiho Oncology as an Associate Director in PV Sciences. At the...Investigator Brochures, clinical summary of the NDA/MAA and product labeling and other applicable documents for clinical trials. +… more
- Bristol Myers Squibb (Princeton, NJ)
- … of US Medical Oncology, Genitourinary (GU). The primary responsibility of this Associate Director is conducting strategic review of promotional materials and ... and objectives with the GU tumor portfolio. As a promotional review lead, this Associate Director role is a strategic partner who is solution oriented and… more
- Novo Nordisk (Princeton, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions + Provide… more
- Bristol Myers Squibb (Princeton, NJ)
- …or GRL as needed + Provide strategic direction (and content input) on US Labeling + Anticipate and interpret key trends and changes in the global/US regulatory ... environment and provide strategic guidance regarding development plans as a result. + Foster positive relationships with FDA. + Build and maintain a strong, collaborative relationship with all key stakeholders including Commercial, Medical Affairs, Promotion &… 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director of Comparator Strategy and Operations is responsible for managing clinical comparator & ancillary supply and sourcing strategies at the ... program, and study levels for Regeneron clinical trials. The associate director will be part of a...Sourcing from low-cost markets + Pooled supplies + JIT labeling + On-demand procurement + Knowledge of regulatory guidelines… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …working within established timelines of investigational product manufacturing, labeling , release, distribution and return/destruction, and/or helping to establish ... of RFP, assumptions and SOW for CROs and IP services vendors ( labeling , packaging, distribution; IVRS/IWRS) + Provides input, reviews, and approves vendor study… more
- Integra LifeSciences (Princeton, NJ)
- …to help improve outcomes. **SUPERVISION RECEIVED** Under direct supervision of Associate Director , Global Marketing - Surgical Reconstruction, TT **SUPERVISION ... product line extensions and/or line trimming, forecasting, pricing strategies, labeling revisions, clinical studies, manufacturing and customer service/operations support… more
