Medical AQP Reviewer

About Abb Vie

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.

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 Abb Vie 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 Abb Vie 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

Abb Vie's UK offices in Maidenhead…