Medical Governance Manager (UK)
Core
Ensure regulatory and ethical compliance for medical activities, acting as the final medical signatory and managing governance frameworks for a global biopharmaceutical company.
Role type
Senior Medical Governance Manager (Pharmaceuticals)
Builds
Compliance policies, SOPs, and risk mitigation strategies for medical and commercial activities
Domain
Biopharmaceuticals / Regulatory Compliance
Required skills
Regulatory framework knowledge (ABPI Code, GCP, ICH), SOP development, audit execution, risk assessment, stakeholder engagement, complaint handling, cross-border compliance management
Preferred skills
Clinical trial design expertise, data interpretation, promotional material review, transfer of values disclosure methodology
Technologies
Compliance and commercial software
Responsibilities
Act as ABPI final medical signatory; monitor and interpret regulatory guidelines; conduct compliance audits; develop and maintain medical governance frameworks; provide expert medical advice on clinical trials and marketing; investigate compliance issues; liaise with regulatory bodies and external stakeholders; manage PMCPA complaints
Seniority
Senior, hands-on IC