Medical Governance Lead

About the role

The Medical Governance Lead is the accountable owner of medical governance, SOPs, compliance, MLR oversight, audit readiness and MAP governance. The role ensures consistent, high-quality and compliant execution of Medical Affairs activities in line with Novartis good practices, local regulations and global medical governance standards. It sits within the Medical Governance, Evidence & Operations pillar and connects Medical Affairs teams with Legal, ERC, Pharmacovigilance and other assurance functions. The role does not hold final approval authority unless explicitly defined and reports to the Head, Medical Governance, Evidence & Operations.

Key responsibilities

• Ensure compliance with Novartis good practice guidelines and country regulations, and maintain country-level medical governance frameworks
• Run periodic monitoring and self-inspections, track governance training assignments and keep evidence inspection-ready
• Support audit preparedness, track audit findings and remediation plans, and identify governance risks and process gaps
• Coordinate governance review forums and committees for timely review of scientific and medical materials
• Review and update Medical Affairs SOPs, monitor adherence and flag deviations
• Act as interface with Legal, ERC, PV, Regulatory Affairs and other assurance functions, including vendor/third-party qualification oversight
• Contribute to governance metrics, dashboards and reporting, and use insights to drive continuous improvement

Required profile

• Ability to measure compliance of Medical Affairs activities against governance standards and SOPs, and to track audit readiness, audit findings closed on time, overdue CAPAs and recurrence rates
• Understanding of SOP review cycles, adoption of harmonized ways of working and on-time completion of mandatory governance and compliance training

Required skills

• Clinical research and clinical trials
• Drug development and health sciences
• Immunology and internal medicine
• Medical information and patient care
• Stakeholder engagement