Medical Governance, Evidence & Ops Manager

Novartis; Hong Kong; On-site; HKD 900,000 - 1,350,000; Full time

Job summary

Novartis is seeking a Medical Governance, Evidence & Ops Manager to lead medical excellence across Medical Affairs. You will establish governance frameworks, drive evidence generation strategies, and optimize medical operations in alignment with global and local standards.

In this strategic role, you will collaborate with Medical Affairs, Regulatory, Ethics & Risk Compliance, Quality and cross-functional teams to ensure compliant, patient-centric execution, timely publications and robust risk

Qualifications

• Advanced degree in Life Sciences or related scientific discipline required.
• Master's degree, PharmD, PhD or MD preferred.
• 2–4+ years of experience in Medical Affairs, Clinical Research, Medical Operations, Evidence Generation, Medical Governance, or related functions.

Responsibilities

• Drive medical governance frameworks and ensure compliance.
• Oversee evidence generation plans and country-level execution.
• Lead medical operations efficiency and implement performance metrics.
• Coordinate cross-functional collaboration with ERC, Quality, Safety and Legal.
• Support portfolio medical information and materials reviews.
• Ensure timely reporting of adverse events and safety issues.

Skills

Medical affairs

Clinical research

Governance

Regulatory liaison

Education

Advanced degree in Life Sciences, Pharmacy, Medicine or related field

Master's degree, PharmD, PhD or MD preferred

Job description

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

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 effectivenessStakeholder 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 support