- 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and immune disorders. **Summary** This 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
- 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
- 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
- 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
- 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
- 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
- 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
- Organon & Co. (Jersey City, NJ)
- …with Commercial, PRT, Global Regulatory Liaisons, Medical Affairs and Worldwide Product Labeling . + Guide and coach team on Organon transformation, efficiency, while ... being accountable for the team's performance. + Provide technical and professional leadership and conduct all appropriate HR activities such as managing performance, development planning, staffing and related people-management responsibilities for personnel… 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
- Bristol Myers Squibb (Madison, NJ)
- …with HA deadlines. + Contribute in the developing of target labeling . **Degree / Experience Requirements** + Bachelor's degree required; advanced scientific ... degree preferred (Masters, PhD, PharmD, BSN, etc.) with 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ability to broadly represent the… more
- Daiichi Sankyo Inc. (Basking Ridge, 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… more
- New York Edge (Staten Island, NY)
- …The data specialist will play a critical role in assisting the Community School Director and New York Edge in running reports and tracking data which details the ... timely and accurate manner + Entering the schedule and labeling activities into required databases + Set up class...into all required systems + Assist the Community School Director to enhance programming through the use of Data… more
- System One (Florham Park, NJ)
- …Quality of Life (QOL), plays a pivotal role in supporting the Senior Director in overseeing regulatory activities related to QOL initiatives. This role involves ... outcomes for our QOL initiatives. Responsibilities + Support the Senior Director in developing and executing regional regulatory strategies for QOL initiatives… more
- Mount Sinai Health System (New York, NY)
- …& Responsibilities:_** Assist registered pharmacists, as directed, in compounding, preparing, labeling , or dispensing of drugs used to fill valid prescriptions or ... medication orders, on in compounding, preparing, labeling in anticipation of a valid prescriptions or medication order, where such tasks require no clinical… more
- Union County College (Cranford, NJ)
- …and esthetically pleasant, physical environment. Under the direction of the Associate Director of Maintenance and Facilities, the Custodial Site assists in the ... personnel. * Identifies staff opportunities and keeps the Associate Director informed. * Prepares requests for purchases of materials,...records of equipment and supplies to ensure compliance with labeling and the requirements of the Right to Know… more