Medical Governance, Evidence & Ops Manager

-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 planning as well as implementation and monitoring of appropriate internal controls within the area of responsibilities.
    • Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable
    • Partner with Medical Lead, Medical Managers, MSLs, Legal, ERC, Quality, Safety and cross-functional teams
    • Facilitate alignment across, local, regional, and global stakeholders

Key performance indicators:

• Works within Ethics & Compliance policies -Achievement of annual targets for medical activities
• Operational excellence metrics achieved
• Execution of evidence generation plans
• Study milestones delivered on time and within budget
• Governance training completion rate
• Audit and inspection readiness status
• CAPA closure effectiveness
• Stakeholder satisfaction and cross-functional collaboration effectiveness

Minimum Requirements:

• Advanced degree in Life Sciences, Pharmacy, Medicine, Public Health, Epidemiology, or related scientific discipline
• Master's degree, PharmD, PhD, or MD preferred

Work Experience:

• 2-4+ years of experience in Medical Affairs, Clinical Research, Medical Operations, Evidence Generation, Medical Governance, or related functions
• Experience supporting or leading clinical studies, RWE programs, or evidence-generation initiatives
• Strong understanding of GxP, medical governance frameworks, healthcare compliance standards, and local regulations
• Experience working in a complex matrix organization
• Knowledge of digital Medical Affairs platforms and analytics tools (preferred)
• Candidate with less experience or qualification will be considered for junior position

Skills:

• Operations Management and Execution
• Collaborating across boundaries
• Project Management
• Capability Building Training
• Clinical Practices
• Clinical Research
• Clinical Trials
• Drug Development.
• Risk Identification and Mitigation
• Health Sciences
• Organization Skills
• Patient Care
• Stakeholder Engagement

Languages :

• Cantonese, English

Additional Specification

• China-HK collaboration on scientific events, education and RWE data generation.