Due to continued global growth, we have an exciting opportunity for an experienced Head of Global Medical Compliance to join us in our UK Headquarters in London.MAIN PURPOSE OF ROLE
The role of the Medical Office is to bring medical/scientific and drug safety related insights and expertise to ADVANZ PHARMA and to be subject matter experts across the following functional areas: medical affairs, medical compliance, patient safety, clinical development and post marketing research and medical operations. This entails engaging and collaborating with healthcare organizations, healthcare professionals and customers - both internal and external - and generating and communicating relevant, meaningful and impactful data. In so-doing, the Medical Office: represents the voice of the patient in all matters; works to ensure that products are supported by relevant, up to date data and retain a positive benefit/risk profile; helps to drive our scientific credibility and reputation as a company; enables stakeholders to make informed choices for patients; operates with due regard to all relevant regulations and compliance requirements.
The role of the Head, Global Medical Compliance is to provide strategic leadership of, and functional ownership and accountability for, all aspects of healthcare professional related compliance in ADVANZ PHARMA. This includes compliance of all ADVANZ PHARMA personnel in general, and of Medical office personnel specifically, with all healthcare applicable company policies and procedures, laws, regulations, and industry codes such as IFPMA and EFPIA (at EU level) and ABPI (for the UK). In addition, the role involves collaborating with and supporting the Global Compliance Officer in the Legal team, to ensure compliance with ADVANZ PHARMA's Code of Conduct and all applicable laws such as anti-bribery, anti-corruption, GDPR and sanctions legislation. This is an important subject matter expert role for the Company on medical compliance; the Head, Global Medical Compliance serves as a senior and informed adviser to the Chief Medical Officer (CMO) on all such compliance related matters.Key responsibilities:
- Provide expert medical / healthcare related compliance insights and guidance to the organization across all business lines and geographies; serve as senior subject matter expert and adviser to the Chief Medical Officer for any healthcare related compliance matter across the organization
- Set and execute medical / healthcare compliance related strategies for the Company in general, and the Medical Office specifically and ensure applicability across global and local organizations. Undertake medical compliance risk assessments to identify areas of focus and ensure identified gaps are built into a strategic plan designed to mitigate company exposure; ensure tactics support the strategy and are implemented according to the plan.
- Ensure that ADVANZ PHARMAs compliance framework including SOPs and guidance pertaining to disclosures, transfers of value, promotional and Good Clinical Practice (GCP) compliance are robust and up-to-date; Define, develop and maintain policies, procedures and process documents governing core Medical Office roles and responsibilities as they pertain to healthcare and medical compliance related topics; Develop, deliver and monitor appropriate training across the organization / Medical Office as applicable
- Undertake the role of Quality Management responsible person and coordinator for the Medical Office, and on behalf of the CMO; establish and Chair regular meetings with the Medical Office Leadership; define the quality management system for the Medical Office as it pertains to matters such as policy and procedure requirements, documentation requirements, onboarding, training, audit preparation and the like.
- Ensure alignment of medical compliance framework with the company's global policies, e.g. Anti-Bribery, Code of Conduct, etc.
- Ensure that Fair Market Value parameters for core healthcare related practices are clearly defined, up-to-date and appropriate for interactions with healthcare professionals at a global, regional and local level
- Track and ensure compliance to local, regional and international standards for disclosure, including FDA, EFPIA and local disclosure requirements. Attester for data reporting in the US aligned to Sunshine Act.
- Conduct regular assessments to ensure that activities performed are compliant with the ABPI Code of Practice; conduct and coordinate training on compliance to ensure competence on the requirements on all aspects of medical compliance where necessary; coordinate company responses for alleged Codes of Practice breaches; Ensure senior management is aware of those areas likely to lead to company exposure; undertake refresher training and 'lessons learned' sessions across the organization as necessary
- Perform or oversee audits both internally and externally with regards to healthcare and GCP compliance to ensure compliance to local, regional and international compliance standards e.g. FDA, EFPIA, ABPI and other local standards
- Member of the Medical Grants and Donations committee, review and approval of requests
- Collaborate with the Global Compliance Officer (Legal) for the ongoing delivery of the Corporate Compliance Programme
- Serve as Medical Office Compliance Champion and representative of the Company Ethics and Compliance Committee providing quarterly Medical Compliance updates
- Deliver high-quality Medical Compliance tailored induction/onboarding to new starters to enable employees to gain awareness and knowledge of industry requirements and help drive positive compliance culture.
- Delivery of Code Case sessions on a monthly basis to the Medical and Commercial teams for improved understanding of code conformity and empowering the right decision-making on activities in order to meet regulatory standards
- Timely completion of monthly report with built-in metrics/dashboards in order to feedback on activities and highlighting contributions. Presenting to the CMO the key compliance deliverables, successes and challenges.
- Maintaining the compliance section on the medical office intranet site with relevant updates
- Any other ad hoc projects as required to meet business needs.