Medical Governance Manager (UK)

Celltrion Group provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world. Celltrion Group offers biologics to about 110 countries, along with more than 30 global partners around the world. With hands-on experience and knowledge accumulated through years of working in the advanced pharmaceutical markets around the world, Celltrion Group has been securing distribution channels and providing patients with biosimilars at affordable prices.

Accountability:

• Compliance with regulatory and ethical standards, ensuring adherence to laws and codes like the ABPI Code of Practice.
• Development and implementation of governance policies and procedures, including Standard Operating Procedures (SOPs).
• Training and education on compliance matters, ensuring staff awareness and understanding.
• Management of compliance-related processes and systems, such as handling complaints.
• Liaising with regulatory bodies and external stakeholders to address governance issues.
• Staying updated on regulatory changes and updating company practices to remain compliant.
• Managing compliance and approval of cross border requests.
• Leadership on disclosure of transfer of values process.

Key Responsibilities:

• Compliance Oversight: Act as ABPI final medical signatory for the company. Monitor and interpret applicable regulatory guidelines (e.g., GCP, ICH, ABPI Code) to ensure compliance to relevant regulatory, ethical industry standards with medical/commercial activities across the organization. Conduct or oversee systematic audits of compliance procedures, identifying and addressing gaps or potential compliance risks and develop mitigation strategies to address them. Lead on disclosure of transfer of values process, including the methodology updates.
• Medical Governance Framework: Develop and maintain a comprehensive medical governance framework, including policies, procedures, and standard operating procedures (SOPs) for medical activities. Ensure effective communication and training of medical governance policies to all relevant staff.
• Medical Advisory Support: Provide expert medical advice on clinical trial design, data interpretation, company sales activities, marketing tools and safety concerns to cross-functional teams. Review and approve medical information used in promotional materials and scientific exchanges with healthcare professionals.
• Risk Management: Conduct risk assessments related to medical activities and implement appropriate risk mitigation strategies. Monitor emerging regulatory trends and potential risks to the company's medical practices. Stay informed about changes in the ABPI Code of Practice and other relevant regulatory and industry standards, and update company practices accordingly.
• Investigative Activities: Investigate potential compliance issues or adverse events related to medical activities. Initiate corrective actions and follow-up on investigations to address compliance concerns.
• Stakeholder Engagement: Handling and processing of registered PMCPA complaints or intercompany dialogues and being the main company representative to external correspondences. Liaise with regulatory bodies and external stakeholders on governance matters, fostering relationships and ensuring alignment. Collaborate with internal stakeholders (e.g., clinical development, marketing, legal), and external medical experts on compliance matters. Present findings and recommendations to senior management on medical governance issues.
• Global Medical Compliance: Support and liaise with global compliance team to align, develop, localise, train and implement any global compliance initiatives within the UK. Support review and risk management of Global activities involving UK HCPs or audience as appropriate according to the ABPI code. Lead responses on all PMCPA complaints or intercompany dialogues and keep global compliance team informed of proceedings.

Work Experience Requirements:

• Degree or equivalent.
• Experience in the pharmaceutical industry, preferably in medical governance/medical excellence.
• Knowledge of relevant regulatory frameworks and industry codes of practice, such as the ABPI Code of Practice, critical for compliance.
• Strong communication and interpersonal skills, necessary for training and stakeholder engagement.
• Ability to write and implement SOPs and other documentation, ensuring clear and effective policies.
• Project management skills, essential for overseeing audits and compliance initiatives.
• ABPI final medical signatory.

Core Competencies:

• Attention to detail, crucial for reviewing compliance documents and identifying issues.
• Analytical and problem-solving skills, for addressing compliance challenges.
• Excellent written and oral communication, for training and stakeholder interactions.
• Strong negotiation skills.
• IT skills, including compliance and commercial software.
• Ability to work under pressure and to strict deadlines, given compliance timelines.
• Leadership and teamworking skills, for collaborating across departments.
• Good time management, ensuring efficient handling of multiple responsibilities.
• Integrity and professional approach, aligning with the company's values and ethical standards.