Director - ABPI Signatory and Medical Reviewer

Job description

Nombre del sítio: UK - London - Brentford
Fecha de publicación: Feb 22 2024

Director - ABPI Signatory and Medical Reviewer

Job Purpose

In the UK, all laws and regulations concerning promotional and non-promotional external interactions are built into the UK ABPI code of practice.

The ABPI Signatory and Medical Reviewer is responsible for providing content governance expertise in support of external engagement activities aimed at HCPs, patients, and/or the public. This individual will work closely with the ABPI Senior Medical Director and other stakeholders from Medical, Commercial and CGA to ensure materials and activities are compliant with the GSK Code and ABPI Code of Practice.
 

This is a Global role and you will therefore work with colleagues across Global and Region Europe, acting as an ABPI subject matter expert to provide guidance, support, and ultimately certification and examination of materials and activities.  The role is of strategic value for minimizing regulatory risks associated with external promotional and non-promotional interactions.  

Key Responsibilities:

·  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 (e.g. GSK Code).
·  Act as a subject matter expert on content governance, copy approval, and the ABPI Code of Practice, providing support, guidance and approval.
·  Provide ABPI Code certification and examination of materials and activities.
·  Support the development and delivery of ABPI capability programmes for both ABPI signatories and content owners to ensure a thorough understanding of the ABPI Code and its practical and consistent application.
·  Collaborate with Legal and Compliance colleagues to proactively identify and mitigate potential risks.
·  Own and support the response to/resolution of ABPI inter-company challenges and PMCPA ABPI complaints.
·  Resolution of internal ABPI Code escalation queries as a member of the ‘ABPI Escalation Squad’
·  Identify issues, themes and/or opportunities for continuous improvement that enhance the quality and compliance of materials and activities.
·  Build and maintain desired business capabilities, including the GSK code signatory capability and the ABPI code signatory capability, within the Independent Medical Reviewers team.
·  Maintain a robust understanding of, and stay up-to-date with changes to, the ABPI Code and other regulatory guidelines, and communicate these updates to relevant stakeholders.
·  You offer cross-functional and multidisciplinary content governance expertise in support of large business projects involving external engagement with customers.
·  You foster and enhance the business acumen of key stakeholders including the Medical Reviewers team, and ABPI signatories, in terms of critically observing the proper implementation of content standards and evaluating the associated regulatory risks.   

Why You?

Basic Qualifications:

·  A medical or pharmacy degree (e.g., MD, PharmD, DVM, or biomedical sciences).
·  Must be a UK registered medical practitioner or a UK registered pharmacist (or capable of UK GMC registration without any additional examinations).
·  Accredited and experienced ABPI signatory with a strong understanding of the UK and EU pharmaceutical regulatory environment (ABPI, PMCPA, EFPIA)
·  Experience in a similar role within the pharmaceutical industry.
·  Experience in the governance and regulatory frameworks applicable in content creation and delivery in both promotional and scientific contexts.

Preferred Qualifications:

·  Additional qualifications in law, ethics, or compliance.
·  Experience in designing and/or delivering training on ABPI Code-related matters.
·  Track record of building and maintaining strong professional relationships within the healthcare industry.
·  People management and/or leadership experience.   
·  Strong analytical skills with attention to detail and the ability to interpret complex information.
·  Excellent communication and interpersonal skills, with the ability to work effectively across multiple functions and therapeutic areas.
·  Demonstrate skills of effective communication including assertiveness, matrix leadership, cross-functional collaboration and problem-solving in fast-paced organizations.
·  Proven ability to work under pressure and to tight deadlines.
·  High level of integrity, professionalism and the ability to manage conflict or differences of opinion.

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