Medical Affairs Governance, Risk and Control

Responsibilities

Development, implementation, and continual improvement of Global Medical Affairs’ quality program as it pertains to regulatory quality, including risk assessment, governance, monitoring, reporting, oversight to audit/inspection readiness and remediation. Represent Global Medical Affairs in company regulatory quality forums (e.g., inspection preparation teams) and ensure cohesive inclusion of Medical with related Company functions and processes (e.g., Global Patient Safety, Regulatory, R&D Quality). Create awareness and buy‑in at all functions and levels of Global Medical Affairs on regulatory process and quality management concepts, best practices, and strategic relevance. Identify opportunities for collaboration and foster communication within and outside of Global Medical Affairs to enable alignment on quality initiatives at the global and local levels and across functions. Provide guidance and collaboration with Process Owners and Subject Matter Experts in ...