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 wit...