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Final Signatory
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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
About the Role
Please read before applying
This is a dual-market final signatory role covering both the UK and Ireland. You will certify and approve promotional and non-promotional material against two codes:
- The ABPI Code of Practice (UK), administered by the PMCPA
- The IPHA Code of Practice (Ireland), alongside HPRA requirements
You will act as the named signatory who confirms each item is accurate, balanced, and a fair and truthful presentation of the facts; that it aligns with the current marketing authorisation; and that it meets the relevant advertising law and codes before it goes live. The role is commercial as much as it is compliant: you will sit close to the Brand teams and help them find workable, code-compliant routes to their objectives.
Job Description
- Provide brand support for the preparation and final signatory approval of promotional and non-promotional material and activities
- Attend Brand Team Meetings to ensure Review agenda/focuses are communicated and understood
- Support the continued implementation of a Code Compliant system for all promotional and non-promotional activities throughout AbbVie and the marketplace, keeping the company in line with the Association of the British Pharmaceutical Industry (ABPI) standards, the Irish Pharmaceutical Healthcare Association (IPHA) Code, the MHRA Blue Guide, the Irish HPRA requirements, 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, approval and certification of materials in accordance with the relevant UK and Irish Codes of Practice
- Make appropriate evaluations when undertaking material reviews, taking into account the risk profile in decision making
- Provide guidance on UK and Irish code requirements to overseas affiliates and the UK/Ireland Affiliate as and when required
- Actively participate in cross-functional Review Projects to build Review standard practices and solutions to meet business needs
- Adhere to the PMCPA Code of Practice for the Pharmaceutical Industry, and the IPHA Code for Ireland, in all aspects of work
- Confidently present code cases to encourage team learning
- Subject Matter Expert for therapy area and seen as the expert by the Brand team
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Key Stakeholders
- Medical Leads
- UK Office of Ethics and Compliance
- UK Legal
- Regulatory Affairs Advertising and Promotion
- Brand Managers, Brand Leads, Business Unit Managers
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Qualifications
- Pharmacy Master's degree or Medical degree essential, with UK registration (GMC or GPhC)
- ABPI final signatory status, or eligibility to become a nominated signatory (product knowledge, relevant experience in and outside the industry, length of service and seniority, and up-to-date, detailed knowledge of the Code)
- Willingness and ability to certify against the IPHA Code for Ireland; existing IPHA experience is an advantage but not essential
- Experience in understanding, analysing and communicating complex pharmacy, pharmacology, and medical issues relating to a range of different therapeutic areas
- Successful completion of in-house AbbVie qualification
- 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
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