Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

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 arrangementsProvide materials approval support for materials, examining in line with company quality standards and the CodeAttend Brand Team Meetings to ensure meetings plans/agenda focuses are communicated and understoodAttend ad-hoc brand team meetings, functional Medical meetings for compliance with company approvals standardsAdvise commercial and medical team project owners on compliant meetings planningSupport 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 campaignsIndependent, 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 makingProvide Guidance on UK Code requirements to Global/overseas affiliates and UK Affiliate as and when requiredActively participate in cross-functional Medical Review Projects to build Medical Review standard practices and solutions to meet business needsSupport evaluation of Materials exception reports and recommendations for corrective actionsAdhere to the ABPI Code of Practice for the Pharmaceutical Industry in all aspects of workConfidently present PMCPA Code cases to encourage team learningSubject 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.

GENERAL ACCOUNTABILITIES:

To comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives AbbVie Ltd.

Qualifications

BACKGROUND/EDUCATION:

Life science degree essential3+ years of approvals experience with ABPI Code quality standards, with up-to-date, detailed knowledge of the CodeExperience in understanding, analysing and communicating complex pharmacy, pharmacology, and medical issues relating to a range of different therapeutic areasExperience in approving meetings in line with quality standards and the Code, including Certification of overseas meetingsExperience in reviewing non-promotional materials including corporate advertising, press releases, market research materialDemonstrated experience in reference checking and copy approval
Additional Information

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