Associate Director, Medical Governance

Job Description Summary

Join Novartis as Associate Director, Medical Governance & Risk Management and play a crucial role in supporting the implementation of a unified governance framework for medical and patient-focused programmes. You will facilitate the roll-out of GxP processes, support self-assessments and audits, manage CAPA, and guide associates in risk and issue management. Your expertise will help maintain excellence in risk and quality management, ensuring compliance and continuous improvement across Medical Affairs.

Location: Dublin, Ireland / London, UK / Barcelona, Spain #LI-Hybrid

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

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 Leads and 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.

Skills Desired

Clinical Research, Clinical Trials, Detail-Oriented, Medical Writing, People Management, Regulatory Compliance, Safety, Waterfall Model

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