Associate Director, Medical Governance & Risk Management

Responsibilities:                                                                                                                

• Support the implementation of the unified governance framework for medical and patient-focused programmes, leveraging the Medical Excellence Governance Board (MEGB) for streamlined consultation and escalation.
• Facilitate connections between local Medical Governance Leads and global experts, contributing to their onboarding, skill development, and effective communication.
• Assist in developing and executing comprehensive self-assessments and controls in Medical Affairs, analysing trends and providing insights for improvement.
• Support audits by preparing, conducting, and managing corrective and preventive actions (CAPA) in line with the annual quality audit plan.
• Guide and mentor associates in managing risks and issues, ensuring alignment with risk and quality management practices.
• Contribute to the development and updates of GxP processes, medical policies, guidelines, and procedural documents.
• Stay updated on industry trends and external demands to proactively address compliance needs and ensure adherence to regulations and ICH guidelines.
• Collaborate with cross-functional teams to drive projects, support capability building, and foster a culture of high ethical standards and compliance.
• Ensure effective training and onboarding processes for Medical Governance Leadsand Medical Affairs associates.
• Act as a key stakeholder in decision-making processes and participate in project teams to drive outstanding results.

Essential Requirements

• Bachelor’s degree in a relevant field (e.g., Medical Sciences, Life Sciences, Medicine or related fields).
• Minimum of 10 years’ diverse experience in clinical, public health, or in the pharmaceutical industry, preferably in medical affairs, clinical development, medical compliance/governance, quality assurance, risk management, regulatory, or related areas. Experience in more than one of these areas is required.
• Strong knowledge of GxP processes and medical guidelines, with a deep understanding of health authority requirements and ICH guidelines.
• Experience in self-assessments, audits, and managing CAPA.
• Experience working with global teams and cross-functional collaboration, including country and/or regional roles.
• Proven experience in driving change, building capabilities, and sustaining a culture of high ethical standards and compliance.
• Excellent leadership and interpersonal skills, with the ability to problem-solve, negotiate, and resolve conflicts.
• Fluent in English, both spoken and written.

Desirable Requirements

• Ability to act independently while incorporating stakeholder feedback and influencing decision-making.
• Strong strategic, analytical, organisational, and planning skills, with business strategy acumen to align governance and risk management with organisational goals.

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.