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In this role, you’ll lead multiple projects, guide teams, and stay hands-on with PK and PK/PD analyses using tools like NONMEM and R. You’ll bring your regulatory know-how, storytelling skills, and passion for mentorship to help drive smarter, faster
Responsible for developing and executing the Medical Affairs strategy in a selection of EU distributor markets where Insulet doesn’t have a direct presence in Europe. In conjunction with the Snr Medical Affairs Manager, the Medical Manager will be
You will be responsible for overseeing the planning, execution, and successful completion of clinical trials, ensuring adherence to timelines, budgets, and regulatory guidelines. As a leader in our research department, you will collaborate with
Develop, implement, and maintain the quality management system applicable to R&D activities (SOPs, work instructions, standards, etc.). Ensure compliance of R&D projects assigned to CMO Office with relevant regulations (e.g., GCP, GVP, GMP, GLP, ISO, ICH,
Act as key point of contact for TPM on all operational aspects - equipment, performance, cycle time, yield etc. Build solid relationships with first tier TPM’s and drug linker TPM’s to monitor manufacturing performance weekly through the application