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Leads the team responsible for ICSR management for a selected project or group of projects as Team Leader; Ensures adequate distribution of tasks for assigned projects and teams and oversees the workflow process; Assures and exerts
Lead, manage and mentor the team on the synthesis of safety data from multiple sources (e.g., clinical trials, postmarking data, literature, cumulative analyses) to support meaningful discussion during SDRs; Contextualize emerging safety trends by
Provide end-to-end QA oversight of DP, IMP manufacturing activities internally and at CMOs, ensuring sustained GMP compliance and supply continuity for clinical trials. Ensure batch release within delegated authority in accordance with applicable GMP
You will lead a critical scientific function that helps ensure robust evidence and decision-making in product development from early exploration to launch and lifecycle support. In this role, you will set direction and create the conditions for a
This Expert Level role provides on‑site regulatory leadership with a strong manufacturing focus, ensuring regulatory considerations are embedded early into site initiatives and day‑to‑day operations. This leader interacts closely with global and