Associate Director, Medical Governance, Risk Management
Novartis
Director, Medical Governance, Risk Management
Novartis
full-time
Posted on:
Location Type: Hybrid
Location: Dublin • 🇮🇪 Ireland
Visit company websiteJob Level
Lead
About the role
- Implement a unified governance framework for medical and patient-focused programmes, ensuring consistency and compliance.
- Lead the centralised Medical Excellence Governance Board (MEGB) to streamline consultation and escalation pathways for Medical Affairs.
- Build and maintain a governance network across GlobalRegional, and Country Medical Affairs, enabling knowledge sharing and joint problem-solving.
- Onboard, support, train, coach, and mentor country Medical Governance Leads (MGLs), ensuring a strong and knowledgeable team.
- Develop and execute comprehensive self-assessment strategies and controls, analysing trends and providing insights for continuous improvement.
- Guide and mentor associates in managing risks and issues, leading investigations and overseeing CAPA for end-to-end resolution.
- Proactively identify compliance gaps and lead cross-functional projects to address and mitigate risks, ensuring proper documentation and remediation.
- Coordinate audits and manage corrective and preventive actions (CAPA) according to the annual quality audit plan.
- Lead and monitor implementation of quality objectives in alignment with global strategy and quality plans.
- Represent the organization at cross-divisional committees, forums, and boards, ensuring alignment and compliance in global projects.
Requirements
- Master’s degree in a relevant field (e.g., Medical Sciences, Life Sciences, Medicine or related fields).
- Extensive relevant work experience (15+ years) across multiple medical programme or study areas, or diverse expertise in clinical, public health, or pharmaceutical industry (including medical affairs, clinical development, compliance, quality assurance, risk management, regulatory).
- Experience in more than one of these areas is required.
- Deep understanding of health authority requirements, ICH guidelines, GxP processes, and medical guidelines.
- Proven experience in leading self-assessments, audits, and CAPA management.
- Experience working with global teams, cross-functional and cross-divisional collaboration, including country and/or regional roles.
- Proven ability to drive change, build capabilities, and sustain a culture of high ethical standards and compliance.
- Excellent leadership, interpersonal, problem-solving, negotiation, and conflict resolution skills.
- Excellent English language skills, both written and spoken.
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
self-assessment strategiesCAPA managementauditsrisk managementcompliancequality assurancemedical guidelinesICH guidelinesGxP processesclinical development
Soft skills
leadershipinterpersonal skillsproblem-solvingnegotiationconflict resolutioncoachingmentoringchange managementcommunicationcollaboration
Certifications
Master’s degree