Medical Governance, Evidence & Ops Manager

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 & ComplianceDrive 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 & OversightSupport 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 ExcellenceDrive 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 CollaborationSupport 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