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This role serves as a close business partner and facilitator of regulatory activities and is expected to contribute to developing sound regulatory strategies globally. The role...
Write and review clinical (and nonclinical) documents for regulatory submissions in the EU and US, such as Module 2.5, 2.7, 2.4, 2.6, integrated summaries of efficacy/safety...
Work with country or global teams to plan and implement Phase IV GMA-sponsored clinical trials, interventional or non-interventional. This includes all aspects of study management...