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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...
The role will provide leadership and strategic direction for assigned programs, ensuring the successful implementation of the quality strategy and/or quality plans to foster a...
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...
Lead and mentor a team of Analytical Subject Matter Experts for both biologics and small molecule drug products fostering innovation and technical excellence; Support the...
You will be responsible for new product implementation (NPI) into a manufacturing facility, and for support of drug substance manufacturing processes during commercial...
As part of our PV team you will be working collaboratively with the Global Product Safety Science Lead (GPSSL) for assigned product(s) as well as with other PV functions, to ensure...