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Sr. Scientist-Global Labeling Lead

Merck

Role: Senior Scientist, Global Labeling Lead, responsible for developing and maintaining compliant labeling content for development and marketed biopharma products, including Core, US, and EU Labeling. Objectives: ensure high-quality, regulatory-compliant labeling documents to support safe product use globally. Responsibilities: lead cross-functional teams to create, review, and approve labeling; provide labeling expertise and strategic guidance; serve as the regulatory labeling contact for global submissions; develop labeling strategies and language for regulatory authorities. Requirements: Bachelor's in a scientific or medical field; at least 3 years of relevant labeling or pharmaceutical industry experience, with experience leading cross-functional teams; strong understanding of regulatory labeling standards and scientific concepts; project management and communication skills. Preferred: advanced degree (M.S., Pharm.D., Ph.D.), experience with regulatory submissions and global labeling standards. High-Value: focus on biopharmaceutical products in development or marketed, with a global regulatory scope, supporting regulatory submissions in US and Europe. WorkSetup: hybrid; travel approximately 10%. #J-18808-Ljbffr Merck

Vacancy posted 11 hours ago
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