Leads clinical support for Regulatory Affairs activities for a clinical program (e.g., health authority documents/responses... trial methodology, statistical principles, and regulatory strategy. Directs study design, protocol development and execution...
Fosters strong partnerships with strategic marketing, medical affairs, market access, sales, legal, regulatory... committee for brand Ensures timely and efficient review of promotional materials and complies fully with all legal, regulatory...
/clinical pharmacology, biometrics, regulatory, drug safety). Responsible for the creation and execution of clinical development... clinical development. Work with Medical Affairs and external opinion leaders to secure new collaborators and present trial...
activities both internally and externally with regulatory, clinical, drug safety, and medical affairs to ensure clinical..., Pharmacovigilance, and Regulatory Affairs stakeholders regarding compliance issues and provides quality guidance and expert...
Medicine, Biostatistics, Clinical Operations, Regulatory Affairs, and CMC to ensure seamless program execution, recognizing the... medicine. The exact title (Medical Director, VP, SVP) will be determined based on the candidate's experience, scope...