- Bristol Myers Squibb (Princeton, NJ)
- …oversight of a team of Global Labeling Strategists responsible for driving labeling strategy and label development as well as managing cross-functional ... the New Product Portfolio (NPP) responsible for driving early labeling strategy and label development + Proactively...prioritizes resources to meet Company objectives + Ensures TPL/ CCDS / labeling documents are prepared and executed in… more
- Takeda Pharmaceuticals (Columbus, OH)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead where you will be responsible for the ... + Lead cross functional teams to develop and update CCDS and other key global labeling documents...JPI, others as appropriate), consistent with the overall product strategy and information in the CCDS , when… more
- Gilead Sciences, Inc. (Boston, MA)
- …**EXAMPLE RESPONSIBILITIES:** + Leads or otherwise contributes to the development of the labeling strategy for multiple products and indications in the oncology ... best practices and standards. + Demonstrates extensive understanding of competitor labeling , strong therapeutic area knowledge, and CCDS /USPI expertise. +… more
- Ascendis Pharma (Princeton, NJ)
- The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling activities across programs and stages of development, with specific ... and supporting global needs as required. The RA Associate Director , Labeling will be overall responsible for...the Global Regulatory Lead for developing key messaging and strategy . Provide labeling advice and expertise… more
- AbbVie (North Chicago, IL)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director Regulatory Affairs, Strategic Global Labeling , combines the knowledge ... Summary of Product Characteristics (EU SPCs) and other Global Labeling . Under the direction of the Director ...they are in-line with business needs. + Presents process, strategy , and product labeling at Senior level… more
- BeiGene (San Mateo, CA)
- …edits and manages approval of amendments + Presents the CCSI to the labeling committee, contributes viewpoint to CCDS development, and reviews company core ... **General Description:** The Senior Medical Director serves as the Product Safety Physician for...CSC agenda items + Leads communication of recommendations to labeling group/other stakeholders + Actively participates in meetings as… more
- Bristol Myers Squibb (Princeton, NJ)
- …Read more: careers.bms.com/working-with-us . **Position Summary** The Established Brands Associate Director is responsible for strategy and execution of medical ... brand continues to be actively commercialized and develop and execute medical strategy for expansion into new markets. + Provide medical assessments of risk/benefit… more
- BeiGene (San Mateo, CA)
- …stage (phase II-III) safety science activities. The position has no direct reports. The Director Safety Scientist is part of a team that performs high quality and ... high complexity product. + Lead execution of signal assessment strategy and assess potential impact to the product safety...contribute to safety summaries to support changes to the CCDS . + Contribute to development of Package Insert and… more
- Bristol Myers Squibb (Princeton, NJ)
- …reporting, contribution to benefit-risk assessment, risk management planning and strategy , and execution of certain post-marketing commitments and ensuring ... Team (SMT) programs, priorities, resources, and milestones. Drafts the early safety strategy plan, the Early Development Safety Roadmap (EDSR). Authors safety data… more