Mission Statement: Celltrion is a combination of the terms “cell” in our body and “Triones,” a guiding star that is also known as the Big Dipper. The name of our company conveys our will to promote the health and welfare of humanity by becoming a “guiding star” in the bio industry. We, Celltrion Healthcare, always work hard to achieve our dream of “rewriting the world bio-history.” We will exert all efforts to create a richer and healthier future for humanity that emphasizes the significance of coexistence and prosperity. Overall Purpose of the Role: To ensure that Celltrion Healthcare UK Limited complies with all relevant regulatory, ethical, and industry standards in its medical and pharmaceutical operations, and to manage and implement governance processes accordingly. 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. Expenditure Responsibilities: Training programs to educate staff on compliance and ethical standards. Auditing processes to ensure compliance, potentially involving external auditors. Retaining services of external compliance advisors Performance Measurement: Annual objectives will be set in conjunction with line manager. Performance will be measured during one-to-one meetings and annually using a Performance Review document. Authority: Approve compliance-related documents, such as SOPs and training materials. Make decisions on governance matters within the scope of the role, ensuring swift action on compliance issues. 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 issue 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