Resumen
Empower efficient, high-quality and compliant execution of medical affairs function by provide the process, policy, standard requirement, risk-based consultation.
The role will serve as the country Medical Governance Lead and Center of Excellence, connecting China Medical Affairs with Global Medical Affairs Medical Governance and relevant partner functions. The position will establish and continuously improve a risk-based governance framework to identify and evaluate risks, define appropriate controls, monitor effectiveness and drive continuous process improvement.
In parallel, the role will lead the Medical Contents Review capability, ensuring robust quality and compliance oversight for external-facing Contents while establishing an efficient and scalable review model across therapeutic areas.
The role is therefore expected to move the organization from primarily transactional review toward proactive, risk-based governance, quality assurance and continuous improvement.
About the Role
1. Strengthen the China Medical Governance
- Serve as the country Medical Governance point of contact / Medical Governance Center of Excellence, providing governance leadership and subject-matter expertise across Medical Affairs activities.
- Timely communicate GMA governance standards, frameworks and requirements into fit-for-purpose China implementation.
- Establish and continuously improve a harmonized and sustainable Medical Governance framework with clear roles, accountabilities, processes, controls and escalation mechanisms.
- Act as a trusted risk expert and strategic enabler for Medical teams, supporting activity owners in identifying risks and opportunities early and engaging relevant partners to enable informed decisions.
- Provide governance consultation for high-risk, novel or complex Medical activities and help teams determine appropriate risk mitigation and controls.
- Ensure Medical governance supports business objectives with appropriate quality and compliance rather than creating unnecessary operational complexity.
2. Lead and shadow Medical Content Review & Quality Oversight
- Lead and shadow the China Medical Contents review operation across therapeutic areas and relevant external-facing Medical/scientific Contents.
- Establish a risk-based, efficient and scalable review model, including review standards, workflows, role clarity, service levels, escalation criteria and quality indicators.
- Lead the dedicated contents review team and ensure effective workload and capacity management across the portfolio.
- Drive consistency of review decisions and reviewer quality through calibration, guidance, knowledge sharing and case-based learning.
- Establish quality assurance mechanisms including risk-based sample checks, quality trending and targeted remediation.
- Partner with relevant global functions to continuously evolve content-review processes, standards and systems.
- Identify opportunities for technology and AI-enabled workflow improvement while maintaining appropriate human medical judgment, governance and accountability.
3. Risk Management, Monitoring & Governance Oversight
- Lead Medical activity risk identification, assessment, mitigation and monitoring in partnership with activity owners and relevant functions.
- Regular monitor Governance or Quality dashboard/system’s KPIs, KQIs translate monitoring data into actionable insights, and proactively identify emerging quality or compliance risks.
- Lead/facilitate medical health checks, governance monitoring and risk-based oversight activities.
- Lead or coordinate Medical self-assessments(SA) and support follow-up of findings and corrective/preventive actions where appropriate by implement the SA strategy form GMA .
- Support cross function (e.g. ERC) to identify, triage, escalation or resolution of the finding or related observation.
- Provide Medical quality and risk updates to relevant country governance/leadership forums, including appropriate insights, risk trends and mitigation plans.
- Ensure appropriate documentation and traceability to support inspection/audit readiness.
4. Issue Management & Escalation
- Support cross function (e.g. ERC) to identify, triage, escalation or resolution of the finding or related observation.
- Partner with Medical leadership and cross-functional governance bodies on complex or high-risk issues.
- Ensure appropriate escalation of issues that cannot be resolved through business-as-usual processes, consistent with the GMA pathway whereby issues may progress from local teams to global Medical Governance through the designated escalation mechanism
- Drive root-cause understanding, corrective actions and organizational learning from Content quality or governance issues.
5. Cross-functional & Global Partnership
Build strong working relationships with:
- China Medical therapeutic-area teams
- GMA Medical Governance / Medical Excellence, Operations & Governance
- Quality
- Ethics, Risk & Compliance
- Legal
- Patient Safety
- Regulatory Affairs
- Scientific Communications / Medical Information
6. Operational Excellence & Capability Building
- Implement governance and Contents-review processes while strengthening quality, risk management and accountability.
- Act as a function SOP manager and Medical SME to ensure the medical owned SOP/WP is properly maintained as Quality requirement
- Develop governance and Contents-review training, onboarding and continuous capability-building programs.
- Build a strong community of Medical reviewers across therapeutic areas.
- Use review data and risk insights to identify recurring issues and systematically address upstream root causes.
- Drive continuous improvement through simplification, transparency and faster decision-making, consistent with the success factors defined by the GMA governance model.
- Partner with technology and AI teams to improve review workflow, knowledge access, quality monitoring and reviewer productivity where appropriate.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.