Medical Governance, Evidence & Operations Lead

About the role

Salary Range: 58 400,00 € - 108 400,00 € Job Description Summary The Medical Governance, Evidence & Operations Lead leads and oversees country level Medical Governance, Evidence Generation, and Operations activities to ensure the highest standards of quality, compliance, scientific rigor, and operational excellence across all Medical Affairs activities. This role is responsible for: - Ensuring end to end medical governance, including adherence to Novartis' good practices, local regulations, global standards, and audit requirements. Manage activities related to PTAs/MAPs and Medical Info. - Leading evidence generation and local clinical studies operations, RWE programs, integrated evidence planning, and collaboration with regional/International/global Medical Affairs teams. - Providing strategic medical guidance, ensuring readiness for evolving regulations, improving processes, and contributing to consistent country Medical Affairs performance. The role ensures that all medical pillars operate as a cohesive unit delivering patient and customer centric, compliant, and efficient outcomes. Job Description Job Dimensions Number of associates: Leads the integrated Medical Governance, Evidence & Operations pillar within the country medical organization. Financial responsibility: Responsible for efficient resource use, overseeing budgets and vendor contracts. Decision making: Accountable for governance decisions, audit readiness, evidence planning and execution oversight, process improvements, and medical operations frameworks with the Country Medical Affairs Head. External/internal stakeholders Interface: Interfaces with Country Medical Affairs Head, Medical TA Head, EE, IMACE, Regional Field Medical Excellence, Global Medical Governance (GMA), Legal, ERC, PV, Purchasing, and cross-functional teams. Impact on the organization: Drives alignment and quality of medical strategy execution, strengthens capability and process harmonization, and ensures compliant and consistent medical excellence delivery. Major Accountabilities Medical Governance Ensure the highest quality standards and compliance of Novartis good practice guidelines and country regulations. Maintain high performance of medical operations, evidence generation, MAPs and Medical Information teams with strong integration in the therapeutic areas. Ensure close collaboration with DRA, Legal, Quality and Compliance (ERC) and Pharmacovigilance to maintain ethical standards of medical teams in coordination with the TAs. Ensure continuous review of SOPs, Medical Affairs audit findings and identify potential processes and solutions for harmonization and improvement. Promote adequate interaction and alignment with regional, international (IMACE) and Global Teams (GMA, SSO), act as point of contact for the relevant stakeholders at local, regional, international or global level; maintain local operational governance by ensuring and actively championing end to end oversight and continuous process improvement. Evidence Generation Evaluate options and opportunities for gathering RWE data from current portfolio and pipeline according to product strategies. Evaluate status of ongoing observational studies, RWE, and other data generation activities. Track budget related to Medical Affairs data generation activities and ensure that activities are appropriately reflected in our financial systems. Operations Assess and define staff training / mindset needs. Ensure medical excellence by coordinating medical processes. Adoption of harmonized ways of working across department. Collaborate with RE & IMACE, excellence teams. Metrics Input Indicators (what the Medical Governance, Evidence & Operations Lead prepares or brings into their work) Completion of all mandatory internal training required for the role. Stewardship of medical pillar plan of action. Process Indicators (how the Medical Governance, Evidence & Operations Lead performs their work): Timely review and compliant approval of evidence generation and governance processes, workflows and activities. Timely completion, approval and quality oversight of all required people-management processes for direct reports (e.g., objective setting, performance reviews, development plans). Output Indicators (what the Medical Governance, Evidence & Operations Lead directly delivers) Delivery of the evidence-generation deliverables according to timelines. Monitoring and deployment of corrective actions toward department compliance with all ERC, quality, regulatory and legal requirements. Outcome Indicators (effects achieved through the Medical Governance, Evidence & Operations Lead's outputs) RWE and evidence-generation quality, demonstrated by rigor, timely delivery and utilization in decision-making. Increased cross-functional alignment in development activities with internal constituents (SSO, CRMA, V&A). Reduction in number and severity of process and policy deviations and audit findings across all department activit

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