GMAIST Medical Reviewer
To provide medical review and approval services (MLR in the electronic approval system, GCMA or equivalent) to the nominated internal Pfizer team(s) to support the appropriate use of Pfizer medicines and successful implementation of Pfizer’s materials, initiatives and programmes in the United Kingdom.
To independently perform fact-check, scientific review and medical approval of promotional and non-promotional materials and activities in line with the requirements of the UK’s The Association of the British Pharmaceutical Industry (ABPI) Code of Practice.
For promotional materials:
Inclusion of appropriate efficacy and safety information to substantiate claims, in particular appropriate context for Real-World Data (RWD) vs Randomized Clinical Trials (RCT)
Ensuring the claims are accurate, truthful, not misleading and aligned with Core Claims/label
Inclusion of obligation information in an appropriate way to meet ABPI requirements
For non-promotional Medical to Medical (M2M) materials:
Ensuring the piece meets the non-promotional requirements of the Code
Ensuring absence of reference to a specific medicine (brand or generic name)
Ensuring the piece does not lead to promotional content and the content is consistent with the scientific references
To ensure appropriate intended audience(s) is/are selected for the nature of the piece. (understanding of the UK health system and roles within the National Health Service (NHS) and payer organizations is required).
To provide solution-focused feedback and recommendations to Piece Owners via GMCA that enable revisions to be made so that messages in materials ensure the appropriate use of Pfizer medicines and compliance with UK regulations.
To acquire and maintain scientific knowledge of Pfizer medicines within nominated therapy area(s) (including those in development) as well as of key competitors and national guidelines relevant in the UK.
To maintain knowledge about UK regulations, Pfizer UK policies relevant to the GCMA, and any additional guidance from the UK and apply these to MLR activity in GCMA.
To work collaboratively with team members and to the agreed timelines. Effectively manage own time and workload.
REQUIRED SKILL SET
Understanding of the typical activities in the UK pharmaceutical industry (promotion, medical education, external partnerships, advisory boards, colleague training, etc). Excellent knowledge of the ABPI Code of Practice, and all applicable laws and regulations related to the promotion of medicines in the UK.
Understanding of the regulations associated with medicines research, such as clinical trials and real-world data generation and the strengths and limitations of different types of data.
Analytic skills: Utilize tools such as OvidSP and other bibliographic databases such as PubMed, Medline, Embase, and Biosis. Ability to examine data, formulate reasonable hypotheses, and design and execute analyses to test them.
Language skills: High fluency in written English and strong functional fluency in spoken English.
Personal skills: Strong organizational skills and ability to prioritize multiple projects and meet deadlines.
Interpersonal skills: Effective influencing and negotiating skills, including when appropriate an ability to guide decision-making for document content strategy. Ability to work well with all levels and roles in cross-functional, global teams. Ability to mentor more junior colleagues and external vendors.
Software: Previous experience with software commonly used to present and analyze data and experience with searching academic databases. (Word, PowerPoint, Excel) is preferred.
Epidemiology: Familiarity with epidemiologic principles and concepts is desirable.
Reports directly to the Senior Medical Manager.
Works closely with the UK Medical Leads and the Code Approval team.
Graduate/Post-graduate in Pharmacy/Life sciences or equivalent degrees.
Good knowledge of medical review and fact-checking requirements gained through relevant industry experience.
Collaboration evidenced by effective team working.
1 to 2 years relevant experience for master’s in pharmacy/life sciences or more than 3 years relevant experience for graduates with a bachelor’s degree.
Prior experience in medical content creation or promotional material review is preferred.
Prior experience in using search tools, developing search strings and assessing search results is preferred.
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