Medical Governance Lead

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.

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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.

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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.

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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