Position SummaryThe International Medical Review Lead reports into the Sr. Director Global Medical Information and Medical Review (GMI-MR) and is responsible for leading the Medical Review function as part of the Medical, Legal, and Regulatory (MLR) review committee. This individual serves as the Medical delegate, ensuring medical accuracy and medical veracity of promotional and non-promotional materials. The International Medical Review Lead will liaise with functional leaders to operationalize robust and compliant procedures for the MLR review process.Additionally, the individual in this role serves as the departmental liaison between headquarters-based Global Medical Information and local countries in the provision of the medical information service in the International region. This includes overseeing service operations in these regions as it pertains to ensuring the provision of high quality, timely, medical information and technical information/specifications, on request, to external (Physicians, Nurses, Pharmacists, other Health Care Professionals (HCPs), patients, caregivers and others), and internal stakeholders either directly or through contracted medical information service providers/contact centers. The employee carries out this role by developing an expert understanding of product data and labeling, associated disease states, relevant literature, treatment guidelines, competitor information, and marketing strategies and tactics across Alexion's therapeutic areas. The position requires a high level of expertise in the disciplines of medical review and medical information, scientific acumen, and cross-functional collaboration, including working closely with GMI-MR team members, as well as regional Medical Affairs, Commercial, Legal, Regulatory, Quality, and Drug Safety.Excellent oral and written communication skills, customer focus, and teamwork are essential for this role. Previous participation in audits is a plus.Direct Reports: External consultants / vendor currently.Principal ResponsibilitiesMedical ReviewWorks collaboratively and develops good working relationships with the Global Medical Affairs Lead (GMALs) and Medical Directors to ensure alignment of company medical strategy. This includes escalating materials accordingly when guidance is required.Serves as the medical delegate on International Medical, Legal, and Regulatory (MLR) review committee, which is responsible for review and approval of all promotional and medical/scientific materials containing information on Alexion's marketed products and compounds in development, as well as the corresponding disease states developed for International markets.Reviews materials and ensures data included are accurate, within context, and presented in a fair/scientifically balanced manner. Verifies the substantiation of all claims and comparisons.
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