Medical AQP Reviewer

AQP (Appropriately Qualified Person) Signatory for the UK Affiliate in line with the ABPI Code of Practice.
Supporting both compliant meeting arrangements approvals for both UK and overseas meetings and the approval of specific non promotional materials for the UK Affiliate in line with the Code of Practice.
RESPONSIBILITIES:
Provide cross therapy area meetings approval support, examining UK meetings and certifying overseas meetings and travel arrangements
Provide materials approval support for materials, examining in line with company quality standards and the Code
Attend Brand Team Meetings to ensure meetings plans/agenda focuses are communicated and understood
Attend ad-hoc brand team meetings, functional Medical meetings for compliance with company approvals standards
Advise commercial and medical team project owners on compliant meetings planning
Support the continued implementation of a Code Compliant system for all promotional and non-promotional activities throughout AbbVie and the marketplace, ensuring the company is in line with the Association of British Pharmaceutical Industry (ABPI) standards, the MHRA blue guide for advertising and promotion and all applicable international Codes of Practice (EFPIA, IFPMA, and respective National Codes and National Regulatory Bodies) at all times.
Provision of workable compliant solutions to support business development opportunities/product launches and contribute to the development of marketing campaigns
Independent, timely, accurate review and approval of materials in accordance with the relevant Codes of Practice.
Make appropriate evaluations when undertaking material reviews, taking into account the risk profile in decision making
Provide Guidance on UK Code requirements to Global/overseas affiliates and UK Affiliate as and when required
Actively participate in cross-functional Medical Review Projects to build Medical Review standard practices and solutions to meet business needs
Support evaluation of Materials exception reports and recommendations for corrective actions
Adhere to the ABPI Code of Practice for the Pharmaceutical Industry in all aspects of work
Confidently present PMCPA Code cases to encourage team learning
Subject Matter Expert for meetings approvals and non-promotional materials and seen as the expert by the Brand teams
ACCOUNTABILITY & SCOPE:
To adhere to the ABPI Code of Practice for the Pharmaceutical Industry in all aspects of work.
To be cognisant of, and agree to adhere to, Medical Division SOPs and Guidelines.
To provide compliant solutions to meet business needs.
Accountable directly to the Medical Review & Code Training Lead.
To comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives AbbVie Ltd.
KEY STAKEHOLDERS:
Medical & Senior Review Advisors
Medical Leads, Head of Medical Affairs
Brand Managers, Brand Leads, Business Unit Managers
Office of Ethics and Compliance
Global Medical and Commercial teams
Note: This job description describes the principal and main elements of the job. It is a guide to the nature and main duties of the job as they currently exist but is not intended as a wholly comprehensive or permanent schedule and is not part of the contract of employment.
Life science degree essential
3+ years of approvals experience with ABPI Code quality standards, with up-to-date, detailed knowledge of the Code
Experience in understanding, analysing and communicating complex pharmacy, pharmacology, and medical issues relating to a range of different therapeutic areas
Experience in approving meetings in line with quality standards and the Code, including Certification of overseas meetings
Experience in reviewing non-promotional materials including corporate advertising, press releases, market research material
Demonstrated experience in reference checking and copy approval

Employment type
Full-time

Work arrangement
Hybrid