Medical Compliance Reviewers x6
Posted on Mar 16, 2021 by WDS Global Limited
Job Title: Medical Compliance Reviewers x6
Job Type: Permanent
Job Location: Ireland
Salary: GBP 65-75,000
Our Client, one of the world's foremost IT Consultancies, is looking to recruit Medical Compliance Reviewers to join their client in Ireland or Switzerland or UK.
Medical Compliance Reviewer
The medical reviewer will serve as a medical representative as part of an international Medical, Legal, Regulatory (MLR) review team.
- Serve as the medical delegate on Global Medical, Legal, and Regulatory (MLR) review committee, which is responsible for review and approval of all promotional and medical materials containing information on pharmaceutical company's marketed products and compounds in development, as well as the corresponding disease states developed for International markets.
- Review materials and ensure data included are accurate, within context, and presented in a fair/scientifically-balanced manner. Verify substantiation of all claims and comparisons. Determine acceptability of references, advise on whether claims are consistent with appropriate approved label, and ensure that the piece is relevant and of utility for the target audience.
- Advise on materials and events designed and produced by Global marketing and medical teams to ensure compliance with company policies and global standards for ethical promotion and scientific interactions.
- Support International marketing and medical colleagues through guidance and provision of information on company products, brand messages and claims that are in compliance with regulatory requirements and applicable external codes of practice, including the ABPI (Association of the British Pharmaceutical Industry), EFPIA (European Federation Pharmaceutical Industries and Associations) and IFPMA (International Federation of Pharmaceutical Manufacturers) codes.
- Ensure standards for promotional claims and non-promotional product information sharing, ensuring promotions and communications adhere to regulations and support appropriate use of products.
- Work collaboratively and develop a good working relationship with the international Marketing and Multi-channel Consultants, Medical Affairs Leads, and Medical Director to ensure alignment to company's marketing and medical strategy. This includes escalating materials accordingly when guidance is required.
- Work collaboratively with cross-functional teams supporting in creation and review of above-country and affiliate/country materials and projects
- Strong scientific acumen and ability to grasp complex therapeutic areas, including rare diseases or orphan drug products.
- Sound knowledge of international and EU and UK medical compliance regulations, codes of practice and their practical application.
- Good multitasking, project management, and organizational skills.
- Solution oriented, positive attitude and excellent interpersonal skills; as well as oral and written communication skills.
- Experience working as part of a multi-national team
- Ability to work cross-functionally with marketing, legal, regulatory, medical affairs
- Advanced pharmacy/medical or bioscience qualification.
- Experience in pharmaceutical industry within medical affairs; experience working on a cross-functional Medical, Legal, Regulatory (MLR) review committee.
Nice to Have:
- Preferable experience as UK nominated signatory (with MHRA) for a pharmaceutical company.
This is a great role for the right candidate, so if you meet all the criteria above, then APPLY TODAY!