- 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… 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
- 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …strategic and operational regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. You may manage complex interactions related ... RA Ad/Promo at Regulatory Project Team meetings. + Represents RA Ad/Promo at labeling meetings and provides strategic regulatory guidance. + Mentors RA Ad/Promo and… more
- Bristol Myers Squibb (Madison, 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
- Union County College (Cranford, NJ)
- …clean, and esthetically pleasant, physical environment. Under the direction of the Associate Director of Maintenance and Facilities, the Custodial Site assists ... custodial personnel. * Identifies staff opportunities and keeps the Associate Director informed. * Prepares requests for...records of equipment and supplies to ensure compliance with labeling and the requirements of the Right to Know… 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