- Takeda Pharmaceuticals (Columbus, OH)
- …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
- 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
- Merck (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR) The Associate Director is responsible for the review and approval of all US ... divisions Office of Promotion and Advertising Review(OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and submissions… more
- Bausch Health (Bridgewater, NJ)
- …your skills 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 **:** +… more
- AbbVie (Mettawa, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Patient Centered Outcomes Research, is responsible for ... functions (eg, Clinical Development & Operations, Regulatory, Commercial). The Associate Director , Patient-Centered Outcomes Research, will support multiple… more
- Lilly (Durham, NC)
- …people who are determined to make life better for people around the world. Associate Director - Quality Assurance (QA) Packaging is responsible for the staffing, ... and Packaging (DAP) production area at Lilly RTP. The Associate Director will help build a strong...and ensure compliance with area procedures and controls for labeling and packaging operations + Foster a strong quality… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position:** Associate Director , Medical Promotional Review Scientist, Neuropsychiatry ... **Location:** Princeton Pike, NJ or Madison, NJ The Associate Director , Medical Promotional Review Scientist plays a critical role in the Medical Strategy team.… more
- BeiGene (Emeryville, CA)
- **General Description:** _The Associate Director , Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages ... in departmental activities **Supervisory Responsibilities:** This position has no direct reports. The Associate Director , Safety Scientist is part of a team that… more
- AbbVie (Irvine, CA)
- …Translational Pharmacokinetics and Clinical Pharmacology group at AbbVie is seeking for an Associate Director . As a member of multidisciplinary teams, this role ... engagement strategy for assets in eyecare, aesthetics, and neurotoxin portfolios. The Associate Director of Clinical Pharmacology will also establish innovative… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …that will inspire you and empower you to shine? Join us as an Associate Medical Director Neurodegenerative Disorders in our Neuroscience Therapeutic Area Unit in ... to our inspiring, bold mission. **POSITION OBJECTIVES:** The Associate Medical Director leads and drives strategy...may have a significant impact on timelines or product labeling . Synopsis / Protocol Development, Study Execution, &… more
- Abbott (Alameda, CA)
- …for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will work on-site at ... CA, location in the Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is to combine knowledge of… more
- Merck (West Point, PA)
- …business for the design, assessment, and improvement of the end-to-end processes. The Associate Director , GCS Process Steward, is accountable to assure that ... ISS clinical trials (300+). GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites across more… more
- Abbott (Alameda, CA)
- …for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - US New Product Introduction ... development and review process to ensure submission approval. + Review and approve labeling to ensure compliance. + Monitor emerging issues and identify solutions. +… more
- Takeda Pharmaceuticals (Lexington, MA)
- …is true to the best of my knowledge. **Job Description** Join Takeda as an Associate Director , US Advertising & Promotion Regulatory Review out of our Lexington, ... development of marketing materials, including representation on global regulatory and labeling teams. + Provide leadership related to issues of importance; provide… more
- Abbott (Alameda, CA)
- …way patients and professionals measure, track and analyze glucose levels. As an Associate Director , project leadership, you will be responsible for Managing one ... budget and on strategy. These activities include coordination of artwork and labeling , in-house and third-party manufacturing, inventory phase in and phase out,… more
- Merck (Rahway, NJ)
- …portfolio of clinical trials. GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites globally. The ... Teams. + Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply chain documentation to support… more
- Gilead Sciences, Inc. (Foster City, CA)
- …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
- ThermoFisher Scientific (Wilmington, NC)
- …( eg PBRER, PSUR, DSUR) as well as other client deliverables (eg labeling reconciliation documents, CTD modules, REMS, RMP and CSR) **Essential Functions:** Manages ... all medical aspects of contracted tasks across the pharmaceutical product life-cycle. General Support: + Ensures tasks delegated to medical monitoring are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials,… more
- WuXi AppTec (Natick, MA)
- …any scale. Beyond chemistry, we offer formulation development, drug product manufacturing, labeling and distribution services in a variety of injectable dosage forms ... and filling formats including the Lipid Nanoparticle (LNP) drug delivery platform. Our comprehensive analytical method development, validation and testing platform will support your needs in TIDES drug development from discovery through clinical to commercial.… 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
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