03 Oct
|
Novartis India
|
India
03 Oct
Novartis India
India
Summary
The Medical Governance Manager is the accountable owner for 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. Operating within the Medical Governance, Evidence & Operations pillar, the role enables robust medical governance frameworks, supports audit readiness, and drives continuous improvement of Medical Affairs processes across therapeutic areas. The role acts as a key connector between Medical Affairs teams, Legal, ERC, Pharmacovigilance (PV), and other assurance functions to safeguard scientific integrity. The Medical Governance Manager does not hold final approval authority unless explicitly defined, and operates under the accountability of the Head, Medical Governance, Evidence & Operations.
About The Role
Key Responsibilities:
Medical Governance Frameworks & Standards
• Ensure the highest quality standards and compliance of Novartis good practice guidelines and country regulations.
• Implement and maintain country‑level medical governance frameworks aligned with Novartis positive practices and global standards.
• Support adherence to local regulations and internal policies across Medical Affairs activities.
• Coordinate governance‑related processes across therapeutic areas to ensure consistency and transparency.
• Own and coordinate governance training assignment tracking and completion reporting; maintain evidence for inspection readiness.
• Run periodic monitoring/self-inspections of Medical Affairs activities and document outcomes and follow-ups.
• Enable end‑to‑end visibility of medical governance activities for the Head, Medical Governance, Evidence & Operations.
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Compliance, Audit Readiness & Risk Management
• Support Medical Affairs audit preparedness, inspections, and follow‑up actions in collaborati
📌 Medical Governance Lead (India)
🏢 Novartis India
📍 India