Medical Governance, Evidence & Ops Manager

• 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.

Skills Desired

Clinical Research, Clinical Trials, Drug Development, Health Sciences, Immunology, Internal Medicine, Medical Information, Patient Care, Stakeholder Engagement