Medical Reviewer
Nityo Infotech Corporation
Serve as the medical delegate on 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 Nordic 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. Ensure translation accuracy for localized material in local language (against global version) and adherence to approved local label (indications, disease state description, population etc. per local label) Advise on materials and events designed and produced by marketing and medical teams to ensure compliance with company policies and Local standards for ethical promotion and scientific interactions. Support 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 (Local 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 Requirements 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 is preferred. Good knowledge of Local and English as well as extensive knowledge of MS Office Good knowledge of international and EU and Nordic’s compliance regulations, codes of practice and their practical application. Strong scientific acumen and ability to grasp complex therapeutic areas. 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 #J-18808-Ljbffr Nityo Infotech
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