- 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)
- …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)
- …license renewals, responses to Health Authority)- Participant and voting member in the labeling development process in the Labeling Working Team (LWT), in ... collaboration with the CDL- Contributes from a medical strategy standpoint to developing the Clinical Study Report (CSR). May review tables, listings, and figures (TLF) and CSR safety narratives- May lead the development and updates of the Investigator's… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThe 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)
- …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
- 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
- Hilton (New York, NY)
- …Astoria New York \(https://www\.hilton\.com/en/hotels/nycwawa\-waldorf\-astoria\-new\-york/\)** is seeking a ** Director of Housekeeping** to unveil a new era ... business forward through innovation and fostering a positive culture\. The ** Director of Housekeeping** is responsible for directing and administering all… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- We are seeking a Director to join our Precision Medicine team. The Director , Precision Medicine will lead Companion Diagnostics (CDx) strategy working closely ... with Senior Director , Precision Medicine CDx and key cross-functional collaborators to...interactions and filings related to Precision Medicine, including product labeling and participates as appropriate in internal and external… 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
- J&J Family of Companies (Raritan, NJ)
- Associate Director , Signal Detection Scientist - 2406212640W **Description** Johnson and Johnson is currently seeking an **Associate Director , Signal Detection ... event data reviews, evaluations of drug safety issues, adverse event dictionaries, core labeling , and Periodic Safety Review preparation * Ability to lead projects *… 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
- AbbVie (Florham Park, NJ)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director Regulatory Affairs Therapeutic Area Head, GRS, is responsible for the ... a product portfolio + Strong experience working with multiple functions (Ad/Promo, Labeling , CMC, devices, Clinical development, etc.) and cross functional teams and… more
- AbbVie (Madison, NJ)
- …position is responsible for developing and executing product life-cycle and labeling strategies in collaboration with scientific and commercial team members across ... must be followed. For problems surrounded by complex rules and regulations, the Director must be able to direct compliance knowledgeably and expeditiously + Must be… 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
