Jobs / Hong Kong / Novartis Pharmaceuticals Corporation
Medical Governance, Evidence & Ops Manager
Novartis Pharmaceuticals Corporation · 🌍 Hong Kong
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About the role
Job Description Summary -In line with overall product strategy, the Medical Advisor is responsible for supporting the design, implementation and execution of Medical Affairs plans for assigned Therapy Area, providing scientific information, helping design & organise clinical studies, building educational dialogue with KOLs and regulatory stakeholders Job Description -The Medical Governance, Evidence & Ops Manager is a strategic leadership role responsible for driving the highest standards of medical excellence, medical governance and operation excellence across Medical Affairs activities to ensure optimal patient outcomes. This role serves as a key enabler of compliant, efficient, and patient-centric medical execution by establishing robust governance frameworks, driving evidence generation strategies and optimizing medical operations aligning with medical strategies. This position works closely with Medical Affairs, Regulatory, Legal, Ethics & Risk Compliance (ERC), Quality, Safety and cross-functional partners to ensure alignment with Novartis standards, local regulations and global Medical Affairs priorities. In line with overall product strategy, this role is also responsible for supporting assigned portfolio, providing scientific information and building educational dialogue with KOLs and cross-functional stakeholders • Job Description Major accountabilities: • • Medical Capabilities, Governance & Compliance • Drive medical capability training plan including AI and governance education • Lead implementation and maintenance of local medical governance frameworks • Drive training compliance, governance communication, and documentation management • Ensure compliance with Novartis Good Practices, local regulations, SOPs, and global Medical Affairs standards • Co-ordinate governance-related activities across therapeutic areas to ensure consistency and transparency • Conduct self-inspections, monitoring activities, and governance reviews • Support audit readiness, including CAPA tracking and risk mitigation • Evidence Generation Strategy & Oversight • Support development and execution of country evidence generation plans aligned with medical and access strategies • Oversee local clinical studies, investigator-initiated studies (IIT), non-interventional studies (NIS), real-0world evidence (RWE) initiatives, research collaboration and Managed Access Programs (MAP) • Monitor study progress, milestones, budgets and vendor performance • Facilitate publication planning and scientific dissemination activities • Medical Operations Excellence • Drive simplification, harmonization, and continuous improvement of Medical Affairs processes • Establish operation metrics, dashboards, and performance indicators • Coordinate operational planning and budget tracking • Support implementation and adoption of Medical Affairs systems and digital tools • Improve ways of working across medical teams through standardization and best practice sharing • Overall product strategy and Cross-functional Collaboration • Support assigned portfolio including provision of scientific information, answering medical enquiries and materials review • Coordinate review and approval of medical materials and locally developed promotional materials; ensure medical materials provided from global or region for stakeholder engagement and events are tailored to local needs, and reviewed/approved per DBE guidelines and local regulations • Ensure medical enquiries are responded to in a high quality, timely manner, and in accordance with applicable standards; establish standard response documents as appropriate • Provide governance and evidence-generation expertise to strategic projects • Responsible for risk identification and assessment, mitigation pla