Head of Medical Compliance, Governance & Diligence (Fractional)
CNX Therapeutics Ltd · GB
14 days agoImpress employers and recruiters.
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About the Role
We are seeking a fractional Head of Medical Compliance, Governance & Diligence to lead oversight of medical compliance, governance, and scientific review activities. This role ensures the highest standards of regulatory, ethical, and industry code compliance across promotional, scientific, and external engagement work. You will own the medical governance framework and play a strategic role in business development, licensing, and acquisition activities by providing medical due diligence, therapeutic assessment, and product portfolio evaluation.
Responsibilities
- Establish, maintain, and improve the Company's Medical Compliance and Governance Framework, including SOPs, policies, and governance processes.
- Provide independent medical oversight of promotional, scientific, and external engagement activities.
- Lead and oversee compliance with pharmaceutical industry codes of practice, ethical standards, and internal medical governance requirements.
- Act as Medical Signatory and provide medical review and approval of promotional and non-promotional materials.
- Provide medical and scientific leadership to Commercial, Regulatory, Quality, and Senior Leadership teams.
- Lead and oversee interactions with healthcare professionals, organizations, key opinion leaders, and other external stakeholders.
- Provide medical oversight of promotional, scientific, and medical activities conducted by distributors, partners, and third-party service providers.
- Provide medical leadership and expertise to business development, licensing, acquisition, product launch, and portfolio optimization activities.
- Provide medical assessment and guidance relating to product quality issues, market actions, shortages, complaints, and other events with potential patient impact.
- Support the management of pharmaceutical industry code complaints, competitor challenges, and compliance investigations.
- Establish and deliver a Medical Compliance training program for employees and third-party partners.
- Monitor emerging medical, regulatory, and industry developments and assess potential impacts.
- Establish medical compliance metrics, monitoring, and reporting mechanisms for Executive Leadership.
- Support internal audits, third-party audits, regulatory inspections, and compliance reviews.
Requirements
- 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.
- 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.
Skills
- Medical Compliance
- Governance
- Diligence
- ABPI Code Compliance
- Promotional Review
- Scientific Review
- Medical Due Diligence
- Therapeutic Assessment
- Product Portfolio Evaluation
- SOP Management
- Policy Development
- Medical Signatory
- Clinical Risk Assessment
- Training Program Development
- Compliance Metrics and Reporting
- Audit Support
Location
- UK
Work Type
- Fractional
- Part-time
Experience Level
- 10+ years pharmaceutical industry experience
- Senior Leadership
Education Level
- UK-registered Pharmacist (GPhC) or Medical Practitioner (GMC)