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Lead the safety strategy of the assigned product(s) during clinical development including Company Sponsored studies, Investigator Sponsored studies, Compassionate Use and Disease...
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...
Overseeing all process development & manufacturing activities within your department to ensure deadlines are met and projects are completed within the budget. Lead, manage and...
Oversee Santhera's global Pharmacovigilance (PV) system, ensuring compliance with regulations and managing PV vendors and activities; Ensure Santhera meets its obligations as a...
You will provide leadership for all Small Molecule QC laboratories related to Lonza’s Visp site. You will ensure adequate resources (staff, laboratory and instrumentation) to...