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You will take charge of leading regulatory CMC strategy and execution for one or more transformative medicine programs. This pivotal role involves developing and implementing...
We are looking for an experienced Regulatory Affairs CMC (RA CMC) Associate Director, who will be responsible for RA CMC strategy support to second line regulatory approvals, as...
Provide strategic medical safety leadership and practical contributions for assigned product(s) in a cross-functional setting; Perform safety signal management and benefit risk...
Act as a specialist in the area of oncology. Represent Regulatory Affairs internally working on a collaborative basis both within Europe and globally as a member of a...
The Director, Immunology European Medical Engagement Lead (MEL) conducts critical activities that support advancing science, educating on evolving clinical practices, transforming...
The Senior Director, Clinical Science will support BeiGene Clinical and Medical assets by successful execution of clinical development programs and deliverables in partnership...
Provide strategic and technical pharmacovigilance advice to Global Patient Safety (GPS), and other regulatory and medical functions within the Medicines Development Unit; Play an...
Manage, prepare, finalise CMC sections of EU IMPD/MAA and rest of world equivalent documents. Oversee teams preparing content, arrange reviews by regulatory, SME peers, senior...
Lead design of preclinical and/or clinical studies needed to support health benefit claims. Author, update and maintain relevant scientific documentation. Work closely with Product...
As a Director, you will be responsible for the successful execution of multiple projects and ensuring client satisfaction. You will provide mentorship, leadership and direction to...
Management of cases with pharmacovigilance and materiovigilance departments. Regular training of Sales resources (place of the radiopharmaceutical in the strategy tree of...
Lead the initial development, approval, and ongoing compliance of product labeling content throughout the product life cycle; track status and maintain documents in controlled...
Responsible for providing strategic regulatory guidance on the global pediatric development in alignment with and within the overall development of a product; Lead multiple...
In the Clinical Trial Execution Service department, your role will support our trial processes and activities in line with our go-to-market strategy for Investigational Medicinal...