Medical Governance Manager

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