Medical Governance, Evidence & Ops Manager

Job description

-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

Responsibilities

-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 educationLead implementation and maintenance of local medical governance frameworksDrive training compliance, governance communication, and documentation managementEnsure compliance with Novartis Good Practices, local regulations, SOPs, and global Medical Affairs standardsCo-ordinate governance-related activities across therapeutic areas to ensure consistency and transparencyConduct self-inspections, monitoring activities, and governance reviewsSupport audit readiness, including CAPA tracking and risk mitigationEvidence

Generation Strategy & OversightSupport development and execution of country evidence generation plans aligned with medical and access strategiesOversee 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 performanceFacilitate publication planning and scientific dissemination activitiesMedical

Operations ExcellenceDrive simplification, harmonization, and continuous improvement of Medical Affairs processesEstablish operation metrics, dashboards, and performance indicatorsCoordinate operational planning and budget trackingSupport implementation and adoption of Medical Affairs systems and digital toolsImprove ways of working across medical teams through standardization and best practice sharingOverall product strategy and Cross-functional CollaborationSupport assigned portfolio including provision of scientific information, answering medical enquiries and materials reviewCoordinate 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 regulationsEnsure medical enquiries are responded to in a high quality, timely manner, and in accordance with applicable standards; establish standard response documents as appropriateProvide governance and evidence-generation expertise to strategic projectsResponsible 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 applicablePartner with Medical Lead, Medical Managers, MSLs, Legal, ERC, Quality, Safety and cross-functional teamsFacilitate alignment across, local, regional, and global stakeholders Key performance indicators: Works within Ethics & Compliance policies -Achievement of annual targets for medical activitiesOperational excellence metrics achievedExecution of evidence generation plansStudy milestones delivered on time and within budgetGovernance training completion rateAudit and inspection readiness statusCAPA closure effectivenessStakeholder satisfaction and cross-functional collaboration effectiveness

Minimum Requirements: Advanced degree in Life Sciences, Pharmacy, Medicine, Public Health, Epidemiology, or related scientific disciplineMaster's degree, PharmD, PhD, or MD preferredWork Experience:2-4+ years of experience in Medical Affairs, Clinical Research, Medical Operations, Evidence Generation, Medical Governance, or related functionsExperience supporting or leading clinical studies, RWE programs, or evidence-generation initiativesStrong understanding of

GxP, medical governance frameworks, healthcare compliance standards, and local regulationsExperience working in a complex matrix organizationKnowledge 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 ExecutionCollaborating across boundariesProject ManagementCapability Building TrainingClinical PracticesClinical ResearchClinical TrialsDrug Development.Risk

Identification and MitigationHealth SciencesOrganization SkillsPatient CareStakeholder Engagement Languages :Cantonese, English Additional SpecificationChina-HK collaboration on scientific events, education and RWE data generation.