Medical Governance Director

4 days ago


Klang, Selangor, Malaysia Novartis Full time

At Novartis, we're committed to helping people with disease and their families.

About the Role

This position is responsible for leading the end-to-end medical governance of regulated activities in alignment with Medical Affairs strategy and priorities. The ideal candidate will have a strong understanding of MA processes, Novartis standards, and country regulations.

The successful candidate will be responsible for monitoring adherence to Novartis processes, standards, and country regulations. This includes supporting data quality and integrity in country MA, coordinating processes for medical information services, and providing governance support to activity owners and teams.

The role requires a deep understanding of risks associated with MA projects/activities and the ability to provide sustainable solutions to deliver these projects. Additionally, the candidate will oversee and monitor local audit & inspection readiness and execution, track deviations, and support implementation/resolution of local CAPA.

A key aspect of this role is collaboration with various stakeholders, including GGO, GDO/TMO, QA, Safety, ERC, Procurement, and others. The ideal candidate will be able to proactively identify root causes and implement actions to improve future audit/inspection performance.

This position offers a unique opportunity to work with a talented team, leveraging your expertise to drive continuous improvement. If you're passionate about delivering high-quality results and driving excellence, we encourage you to apply.



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