Director, Medical Governance, Risk Management
Novartis
Associate Director, Medical Governance, Risk Management
Novartis
full-time
Posted on:
Location Type: Hybrid
Location: Dublin • 🇮🇪 Ireland
Visit company websiteJob Level
Senior
About the role
- 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 Leads and Medical Affairs associates.
- Act as a key stakeholder in decision-making processes and participate in project teams to drive outstanding results.
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.
- 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.
Benefits
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GxP processesmedical guidelinesself-assessmentsauditsCAPArisk managementregulatory compliancequality assuranceclinical developmentmedical affairs
Soft skills
leadershipinterpersonal skillsproblem-solvingnegotiationconflict resolutioncollaborationcommunicationmentoringcapability buildingchange management