- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, 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
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with research laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard ... problems of some complexity. This position makes decisions with consultation. Responsibilities:Planning for Development : Manages multiple CMC development projects. Leads submission teams with supervision. Acts as point of contact to cross-functional teams on… more
- Merck & Co. (Jersey City, NJ)
- …Key Customer Leader (VKCL), Vaccine Medical Affairs Leader (VMAL), Region Medical Director (RMD) as well as other members of the extended team.-Territory ... needs and our Company's vaccine attributes in accordance with product labeling , and CDC and professional society recommendations.Providing Company Vaccine management… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …at Novo Nordisk, Inc. RelationshipsThe fellow will report to the Fellowship Director throughout the two-year program and will also have a reporting relationship ... validity and medical accuracy, as well as consistency with the FDA-approved labeling . Assist the Promotional Review Board (PRB) team to ensure all promotional… more
- J&J Family of Companies (Raritan, NJ)
- Associate Director , RA Labeling Product Leader (1 of 2) - 2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an Associate ... Director , RA Labeling Product Leader (1 of 2) in Raritan, NJ; Titusville, NJ; Horsham, PA; Toronto, Ontario (CA); UK (High Wycombe); Netherlands (Leiden); Belgium… more
- AbbVie (Florham Park, NJ)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs, Strategic Labeling is responsible for setting ... cross-functional, multidisciplinary, therapeutic teams, and executing multidivisional initiatives for labeling activities for drugs, devices and combination products in… 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
- Bristol Myers Squibb (Madison, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . ** Director , Medical Safety Assessment Physician (Immunology)** **Functional Area Description** ... Develop strategy for signal evaluation and document outcome. . Lead safety labeling activities for assigned products/program. Act as the Safety Subject Matter Expert… 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
- J&J Family of Companies (Raritan, NJ)
- Associate Director , North America Regulatory Lead - 2406196976W **Description** Johnson & Johnson Innovative Medicine is recruiting for Associate Director , North ... their potential. At Johnson & Johnson, we all belong. The Associate Director , Regulatory Affairs will be responsible for the development, implementation, and… more
- J&J Family of Companies (Union, NJ)
- Director RA Dietary Supplements - 2407024953W **Description** Kenvue is currently recruiting for: Director , Regulatory Affairs, Dietary Supplements This position ... reports to the Senior Director , Regulatory Affairs and is based at Skillman, NJ...shape internal product development & claims, ingredient review and labeling processes such that they are efficient, compliant and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …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 Team (LWT), in collaboration with the CDL +… more
- J&J Family of Companies (New Brunswick, NJ)
- Director , Medical Safety Officer (Neurovascular) - 2406209070W **Description** **Johnson & Johnson, is recruiting for a Director , Medical Safety Officer ... categorization of product/product families. Review and provide input on: mitigations, labeling and internal and customer safety training materials directed to… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global regulatory guidance to ... biologics/vaccines, and in the rare disease space. In this role, the Director defines and implements regulatory strategies; works with cross-functional project teams… more
- Merck (Rahway, NJ)
- …(GCS) organization is accountable for the end-to-end supply chain (planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites and ... & Development Division's IT) to serve our company's patients. The GCS Senior Director of Compliance is a key accountable leader on the GCS Operational Excellence… more
- Sanofi Group (Bridgewater, NJ)
- …you thought was possible. Ready to get started? The Clinical Research Director (CRD), Dupilumab, Immunology and Inflammation Therapeutic Area is responsible for the ... participates to the review process for protocols, study reports, labeling , and contributes/supports interactions with regulatory agencies and ethics committees.… 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
