## [Medical Governance Lead](/req-10088374-medical-governance-lead "Medical Governance Lead")
Job ID REQ-10088374
Sep 24, 2026
LOC_IN
### 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 good 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.
- undefined
Compliance, Audit Readiness & Risk Management
- Support Medical Affairs audit preparedness, inspections, and follow‑up actions in collaboration with Quality, Legal, ERC and PV
- Track, document and monitor audit findings, observations and remediation plans.
- Identify governance risks and process gaps and escalate appropriately.
- Support and coordinate medical governance review forums/committees (as applicable) to ensure timely, compliant review and documentation of scientific/medical materials.
- Contribute to continuous improvement initiatives following audits or internal reviews.
- undefined
SOPs, Processes & Ways of Working
- Coordinate periodic review and update of Medical Affairs SOPs (Standard Operating Procedures) and governance documentation.
- Support implementation of updated processes and guidance through clear communication and training inputs.
- Monitor adherence to defined governance processes and flag deviations.
- Ensure governance guidance and process support for transparency/disclosure obligations and conflict-of-interest risk mitigation (in alignment with relevant policies).
Cross‑functional Governance Interfaces
- Act as a key interface between Medical Affairs and Legal, ERC, PV, Regulatory Affairs and other assurance functions.
- Support governance alignment for medical activities such as Medical Information, MAPs (Managed Access Programmes) and evidence generation activities, without duplicating ownership.
- Support governance aspects of vendor/third-party qualification and oversight for Medical Affairs activities (as applicable).
- Enable timely and compliant execution of Medical Affairs initiatives through early governance engagement.
Governance Reporting & Insights
- Contribute to governance‑related metrics, dashboards and reporting as defined by the Medical Governance, Evidence & Operations pillar.
- Support preparation of governance updates for internal reviews and leadership forums.
- Ensure governance documentation and records meet data integrity expectations (complete, traceable, inspection‑ready).
- Use insights from audits, metrics and operational feedback to inform continuous improvement actions.
- undefined
Essential Requirements:
· % compliance of Medical Affairs activities with governance standards and SOPs
- Number and trend of governance deviations
- Audit and inspection readiness status at any point in time
- % of audit findings closed within agreed timelines
- Number of overdue CAPAs
- Recurrence rate of similar audit findings
- % of SOPs reviewed and updated as planned
- Adoption rate of harmonized Medical Affairs ways of working
- % on‑time completion of mandatory governance and compliance training
- Trend in governance issues linked to capability or training gaps
- Timeliness of governance support to medical initiatives
- Use of governance metrics and insights to drive improvement actions
### Role Requirements
**Why Novartis:** Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? [https://www.novartis.com/about/strategy/people-and-culture](https://www.novartis.com/about/strategy/people-and-culture "https://www.novartis.com/about/strategy/people-and-culture")
**Benefits and Rewards:** Learn about all the ways we’ll help you thrive personally and professionally.
[Read our handbook (PDF 30 MB)](https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf)
Division DIV_IM
Business Unit Other
Location LOC_IN
Site Mumbai (Head Office)
Company / Legal Entity IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area FCT_RD
Job Type Full time
Employment Type Regular
Shift Work No
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Job ID REQ-10088374
### Medical Governance Lead
[Apply to Job](https://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/Mumbai-Head-Office/Medical-Governance-Lead_REQ-10088374 "Apply to Job")