Medical AQP Reviewer

AbbVie; Taplow; On-site; GBP 65,000 - 95,000; Full time

Job summary

AbbVie UK is seeking an AQP Signatory to oversee compliant approval processes for UK and overseas meetings, and to certify non-promotional materials in line with ABPI Code and MHRA guidance.

The role requires deep ABPI Code knowledge, life sciences background, and ability to guide global and UK teams in compliant meeting planning and materials reviews.

Qualifications

• 3+ years of ABPI Code approvals experience.
• Strong knowledge of UK Code of Practice.
• Ability to assess risk and approve meetings across UK/overseas.
• Experience reviewing non-promotional materials.
• Experience with cross-functional teams.

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 ABPI standards and applicable Codes.
• 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

Skills

ABPI Code knowledge

Regulatory approvals

Pharmacovigilance

Cross-functional collaboration

Medical/pharmaceutical knowledge

Education

Life science degree

Job description

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

QUALIFICATIONS:

• 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