Medical AQP Reviewer

Company Description

About AbbVie

AbbVie'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 AbbVie, please visit us at www.abbvie.co.uk. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

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
  
  

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.

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
  
  

Additional Information

AbbVie's UK offices in Maidenhead prioritize accessibility and employee well-being, creating a welcoming environment for everyone. The office includes a large car park for easy access, as well as step-free entry, accessible restrooms, and elevators to accommodate individuals with mobility challenges. The workspace features assistive technologies and adaptable workstations, fostering an inclusive culture. Additionally, there is a dedicated quiet zone for those who prefer to work without distraction. This area maximizes natural light and is strategically positioned for easy access with minimal noise disturbances. If you need specific information or have questions about accessibility arrangements, please let us know during the process.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html