Head of Medical Compliance, Governance & Diligence (Fractional)

The Opportunity

Are you a medical compliance leader ready to shape the governance framework of a growing organisation? We're looking for a fractional Head of Medical Compliance, Governance & Diligence to lead oversight of our medical compliance, governance and scientific review activities ensuring the highest standards of regulatory, ethical and industry code compliance across all promotional, scientific and external engagement work.

You'll take ownership of our medical governance framework, including medical compliance procedures, ABPI Code compliance and promotional review processes, shaping how we operate at every level. Beyond governance, you'll play a strategic role in business development, licensing and acquisition activity; providing medical due diligence, therapeutic assessment and product portfolio evaluation to support our growth.

What You’ll Be Doing

• Establish, maintain and continuously improve the Company's Medical Compliance and Governance Framework, including ownership of Medical Compliance SOPs, policies and governance processes, ensuring they remain current, effective and aligned with regulatory and industry expectations.


• Act as the Company's lead medical compliance professional, providing independent medical oversight of promotional, scientific and external engagement activities.


• Lead and oversee compliance with applicable pharmaceutical industry codes of practice, ethical standards and internal medical governance requirements, including the ABPI, EFPIA and relevant local market codes where applicable.


• Act as Medical Signatory and provide medical review and approval of promotional and non-promotional materials, ensuring all communications are scientifically accurate, balanced and compliant.


• Provide medical and scientific leadership to Commercial, Regulatory, Quality and Senior Leadership teams, supporting informed decision-making across the product portfolio.


• Provide medical leadership and oversight for interactions with healthcare professionals, healthcare organisations, key opinion leaders, professional societies, patient organisations and other external stakeholders, ensuring activities are scientifically robust, compliant and supported by appropriate governance processes.


• Provide medical oversight of relevant promotional, scientific and medical activities conducted by distributors, partners and third-party service providers on behalf of the Company.


• Provide medical leadership and expertise to business development, licensing, acquisition, product launch and portfolio optimisation activities through medical due diligence, therapeutic area assessment, portfolio evaluation, independent clinical risk assessment and review of investigator-sponsored research proposals where appropriate.


• Provide medical assessment and guidance relating to significant product quality issues, market actions, shortages, product complaints, product liability matters and other events with potential patient impact.


• Support the management of pharmaceutical industry code complaints, competitor challenges and compliance investigations, providing medical and scientific expertise as required.


• Establish and deliver a Medical Compliance training programme, ensuring employees and third-party partners understand their responsibilities under internal procedures and industry codes.


• Monitor emerging medical, regulatory and industry developments, assessing potential impacts on the Company's products, activities and strategic objectives.


• Establish appropriate medical compliance metrics, monitoring and reporting mechanisms, providing regular updates to Executive Leadership on compliance performance, risks and emerging trends.


• Support internal audits, third-party audits, regulatory inspections and compliance reviews relating to medical compliance and governance activities.

What We’re Looking For

Essential

• UK-registered Pharmacist (GPhC) or Medical Practitioner (GMC), eligible to act as an ABPI Final Signatory.


• Previous experience as an ABPI Final Signatory.


• Significant pharmaceutical industry experience (10+ years) in Medical Affairs, Medical Compliance, Medical Governance or related functions.


• Expert knowledge of the ABPI Code, PMCPA requirements, MHRA advertising requirements and EFPIA standards.


• Experience establishing and maintaining medical compliance and governance frameworks, SOPs and policies.


• Experience providing independent medical review and approval of promotional and non-promotional materials.


• Experience managing compliance investigations, code complaints, audits and inspections.


• Strong scientific and clinical evaluation skills with the ability to assess risk and patient impact.


• Proven ability to influence and challenge senior stakeholders across Medical, Commercial, Regulatory and Quality functions.

Desirable

• Existing or previous Head of Medical Compliance, Medical Governance Lead, Medical Director or Medical Affairs leadership experience.


• Experience supporting licensing, acquisitions, due diligence and business development activities.


• Experience overseeing distributors, partners and third-party service providers.


• Experience supporting product launches and lifecycle management.


• International compliance experience.


• Experience reporting compliance and governance matters to Executive Leadership or Board-level committees.