Associate Director, Medical Governance & Risk Management

Summary

LOCATION : Barcelona, London or Dublin

The Associate Director of Medical Governance & Risk Management has a crucial role in supporting the implementation of the established unified governance framework for medical and patient-focused programs within our organization. This role is responsible for facilitating the roll-out of GxP processes, supporting self-assessments and audits, managing CAPA, and guiding associates in quality issue management. The Associate Director will actively contribute to maintaining excellence in risk and quality management within Novartis Medical Affairs

About the Role

Major accountabilities :

• Provide support in the implementation of the established unified governance framework for medical and patient-focused programs. Leverage the centralized Medical Excellence Governance Board (MEGB) to streamline consultation and escalation pathways for local and global Medical Affairs organizations
• Facilitate connections between local Medical Governance Leads (MGLs) and global experts within MEOG and Global Medical Affairs (GMA), contributing to onboarding, skill development, and effective communication flow.
• Assist in the development and execution of comprehensive self-assessments and controls in Medical Affairs, analyzing trends and findings, and providing insights for continuous improvement.
• Support audits by assisting in the preparation, conduction, and management of corrective and preventive actions (CAPA) in accordance with the yearly quality audit plan.
• Guide and mentor associates in managing risks and quality issues, ensuring alignment with risk and quality management practices. Assist GMA associates, through the role of Business Functional Representative (BFR / Quality Issue owner), contributing to investigations and ensuring proper management of CAPA for end-to-end resolution.
• Contribute to the development and updates on GxP processes, medical policies and guidelines, global business processes and procedural documents.
• Stay updated on industry trends and external demands to proactively address compliance needs. Assist in ensuring compliance with medical governance regulations, health authority requirements, and ICH guidelines. Ensure monitoring of training compliance for GMA associates.
• Collaborate with cross-functional teams to drive projects and achieve outstanding results. Support initiatives for creating stronger organizations and a culture of high ethical standards and compliance.
• Collaborate with the Medical capabilities function to ensure effective training and onboarding processes for MGL, MEOG and Medical Affairs associates.
• Act as a key stakeholder in decision-making processes and actively participate in project teams to drive outstanding results.
• Demonstrate strong leadership skills and the ability to work across functions, countries, and cultures.
• Utilize strategic, analytical, organizational, and planning skills to support the implementation of the governance framework.
• Act as a liaison between scientific and business functions, fostering collaboration and effective communication.
• Possess a strong business strategy acumen to align the medical governance and risk management with organizational goals and objectives

Key performance indicators :

continuous improvement is ensured for own processes

Minimum Requirements :

Work Experience and skills :

Languages :

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