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The Global ABPI Director role plays a critical role in ensuring global and European regional promotional and non-promotional activities/materials in scope of ABPI comply with the internal GSK processes/policies as well as ABPI requirements. This role will sit within the Global Medical Information & Content Approval (GMI & CA) team. This individual will work closely with stakeholders from Medical and Commercial within Global and Europe Region as well as other Global ABPI Directors and UK ABPI team to provide consistent and accurate advice regarding interpretation and application of the ABPI Code to minimise regulatory risks associated with external promotional and non-promotional interactions.
Job Responsibility:
Review and approve promotional and non-promotional materials and activities to ensure compliance with the ABPI Code of Practice, as well as with other relevant regulations and company policies
Maintain a robust understanding of, and stay up to date with changes to, the ABPI Code and other regulatory guidelines
Act as a subject matter expert on the ABPI Code of Practice providing advice, guidance and approval
Support the response to/resolution of ABPI inter-company challenges and PMCPA ABPI complaints
Facilitate the development and delivery of ABPI capability initiatives
Conduct assessments of Global AQPs (Appropriately Qualified Person) to ensure they have the right level of expertise and competencies
Collaborate with Legal and Compliance colleagues to proactively identify and mitigate potential risks
Identify issues, themes and/or opportunities for continuous improvement
Provide cross-functional and multidisciplinary content governance expertise in support of large business projects involving external engagement with customers
Act as a mentor to Global AQPs/content approvers within the GMI&CA team
Act as a delegate of the Senior Director, Global ABPI Compliance & Governance for reviewing and certifying Global Grants & Donations, as needed
Apply an enterprise mindset and identify ways in which ABPI Code might impact global activities and escalate as needed
Requirements:
Previous experience working as a nominated Final Medical ABPI Signatory with a strong understanding of the UK and EU pharmaceutical regulatory environment (ABPI, PMCPA, EFPIA)
A GMC-registered doctor or GPhC-registered pharmacist who is able to be a nominated final signatory
Significant and varied experience working in the pharmaceutical industry ensuring compliance with ABPI Code
Experience responding to PMCPA complaints
Excellent written and verbal communication skills with experience in a highly matrixed organisation
Ability to summarise complex issues succinctly and effectively to understand and make decisions quickly
Ability to proactively evaluate risks and potential issues as they relate to ABPI certification or examination and propose effective solutions
Demonstrates ability to work effectively under pressure and manage across the enterprise at all levels
Collaborative, decisive and solution-oriented approach with an enterprise mindset
Excellent communication and interpersonal skills, with the ability to work effectively across multiple functions and therapeutic areas
Nice to have:
Experience in Global or Regional or Above country Medical Affairs
Experience in designing and/or delivering training on ABPI Code-related matters
Experience working in Specialty, Oncology, Vaccines or General Medicine therapy areas
Track record of building and maintaining strong professional relationships within the healthcare industry
What we offer:
Competitive salary
Annual bonus based on company performance
Healthcare and wellbeing programmes
Pension plan membership
Shares and savings programme
Hybrid working model (Performance with Choice programme)