Medical Review Manager
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A leading global pharmaceutical company has a new vacancy for a Medical review manager to join their expanding Central London team. The company has a superb pipeline and operates in over 90 countries around the world. The Medical review and GMI manager is responsible for performing accurate and detailed scientific/medical review of promotional materials generated by the Global Commercial department as well as non- promotional/medical affairs-generated materials within Global Medical Affairs. He/she provides timely and accurate reviews of these materials in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs.
Job Responsibilities:
- Responsible for scientific information contained in the company's global promotional and non-promotional materials (eg, medical communication materials, training materials, and advisory board materials) is accurate, not misleading and is medically relevant.
- Acquire and maintain expert understanding of product, associated disease states, relevant literature, treatment guidelines, and thorough knowledge of the label for assigned therapeutic area.
- Ensure content is well-substantiated by scientific data (verifying the content is accurately cited/properly referenced); check authenticity and validity of references; determine that references in promotional materials specifically support product claims made in the material; and ensure the context of the reference is appropriately reflected in the promotional claim(s) in the material.
- Verify the content of promotional material is truthful, balanced, scientifically rigorous, and is consistent with approved product labelling.
- Verify scientific content is understandable by the intended audience.
- Anticipate and recognize when to escalate to manager/medical team to resolve higher risk or complex issues.
- Understand that recommendations, actions and decisions made for promotional materials are critical in ensuring compliance with applicable regulatory/practice standards pertinent to the promotion of pharmaceutical products.
- Provide quality check of both promotional and non-promotional materials when needed.
- If needed/appropriate, support content development of global Medical Information responses/activities.
- Additional duties as assigned.
Skills and Requirements:
- Pharmacist, PhD or equivalent degree.
- Prior exposure to review of both promotional and non-promotional materials is required.
- Research - ability to understand and interpret medical research design protocols, advanced statistics and research assessment methodologies
- Attention to detail
- Flexibility to complete assigned tasks in high quality
- Good communication skills, proficiency in English (written/spoken), any other language is an advantage
- Team oriented personality with strong collaboration abilities both internally and externally
- Product Knowledge - Comprehensive understanding of the medical/therapeutic usage of the products. Expert published medical literature searching and evaluation techniques.
- Regional Regulations - Detailed understanding of the regional regulations and reporting requirement for adverse effects and medical communications.
- Flexibility and responsiveness - Ability to anticipate change and adapt strategies to maintain program integrity and accomplish the company's business objectives
- Relationship building - Ability to cultivate a wide network of relationships both internally and externally and promote a team environment
- Sense of ownership and result orientation
- Proficiency in MS Office applications
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Zico Dervish on +44 203 319 3031 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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