Medical Governance Lead

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. Key Responsibilities:Medical Governance Frameworks & StandardsEnsure 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.undefinedCompliance, Audit Readiness & Risk ManagementSupport Medical Affairs audit preparedness, inspections, and follow‑up actions in collaboration with Quality, Legal, ERC and PVTrack, 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.undefinedSOPs, Processes & Ways of WorkingCoordinate 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 InterfacesAct 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 & InsightsContribute 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.undefinedEssential Requirements:· % compliance of Medical Affairs activities with governance standards and SOPsNumber and trend of governance deviationsAudit and inspection readiness status at any point in time% of audit findings closed within agreed timelinesNumber of overdue CAPAsRecurrence rate of similar audit findings% of SOPs reviewed and updated as plannedAdoption rate of harmonized Medical Affairs ways of working% on‑time completion of mandatory governance and compliance trainingTrend in governance issues linked to capability or training gapsTimeliness of governance support to medical initiativesUse of governance metrics and insights to drive improvement actions