Clinical Labeling Project Coordinator

Clinical Labeling Operations Locations: Thousand Oaks, El Segundo, Frederick, Oceanside, or Foster City, CA/MD. Essential Functions: Coordinate clinical labeling implementation with Regulatory Affairs, QA, Supply Chain, PMs, and global packaging sites. Create/review clinical and business continuity labels and map content in Bartender . Ensure label content matches source documents and regulatory requirements. Coordinate timelines and requirements with Regulatory Affairs. Lead operational excellence projects and author SOPs, guidelines, and work instructions. Support labeling updates and departmental objectives. Requirements 6+ years relevant experience + BS/BA, or 4+ years + MS. Pharmaceutical/regulated-industry experience required. Clinical/commercial supply chain experience preferred. Knowledge of FDA, cGMP, and regulatory guidance . Strong project coordination, communication, and technical writing skills. Microsoft Office proficiency. Artwork/labeling production experience preferred; Bartender experience is a bonus.

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