Senior Manager, US Medical Review

This is what you will do: The Senior Manager, US Medical Review will sustain and promote Alexion’s professional standing and integrity amongst patients, health care professionals and the pharmaceutical / biotech industry by providing high quality Medical Review of all material used by the Commercial and Medical teams. This role is responsible for developing and maintaining current, broad, and in-depth knowledge of pathophysiology, pharmacotherapy, and patient outcomes associated with assigned Alexion products and disease states. As necessary, this individual may support broader activities in Medical Communications including Medical Education and Scientific Communications. The employee carries out this role in accordance with departmental SOPs, corporate policy, and other legal and regulatory requirements. You will be responsible for: Will provide essential medical and scientific expertise, review, advisement, and oversight to support development of high quality promotional and medical materials, internal training materials, and communications as part of the Promotional Review Committee (PRC) and Medical Review Committee (MRC). Demonstrated success in negotiating and influencing stakeholders. Developing and maintaining current, broad, and in-depth knowledge of pathophysiology, pharmacotherapy, and clinical outcomes associated with assigned Alexion products and disease states. Supporting the generation of therapeutic area metrics and analytics to aid in load management and forecasting future resources. Assisting in the development and delivery of various presentations to internal colleagues (e.g., medical information inquiry metrics and customer insights; training of commercial and medical field teams on medical information procedures; medical booth training at medical congresses) As applicable, potentially creating content for Medical Affairs and/or assisting in the review, fact-checking of data points, assessment of appropriateness of references cited in materials submitted to the Promotional and Medical Review Committees. As applicable, reporting any product quality complaints and adverse events to Quality Assurance / Drug Safety per corporate policies. As applicable, supporting various operational initiatives including development and maintenance of SOPs; training modules; database/system enhancements; vendor oversight; etc. As applicable, providing support to broader activities in Medical Communications, including Medical Education and Scientific Communication. You will need to have: Advanced scientific degree in pharmacy (PharmD) or related science (PhD, MD) required with 3 years of medical information or medical communications experience in the pharmaceutical/biotech industry. Understanding of drug development, US (FDA) and global (e.g. EMEA) regulations and reporting requirement for reporting pharmacovigilance events and product quality complaints. Strong written and verbal communication skills. Proficiency in literature searching skills. Proficiency with Microsoft Office Suite. Attention to detail. Self-motivation to drive for results. Excellent organizational, time management and prioritization skills. The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. We would prefer for you to have: 2+ years of experience providing medical review as part of an MLR team. 5+ -years of relevant experience in academia and/or pharmaceutical/biotech industry. Or 2-years of relevant experience in pharmaceutical/biotech industry. Prior experience working with promotional/medical review systems (e.g., Veeva PromoMats). Experience creating medical affairs content. Adept at learning new software / applications. Training or past experience in assigned therapeutic area(s) or rare disease, immunology, nephrology, hematology, oncology, neurology, enzyme-replacement therapies. Experience working on product launches. Completion of a post-PharmD Fellowship in the pharmaceutical/biotech industry. The annual base pay (or hourly rate of compensation) for this position ranges from $116,710 to $175,064. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. #J-18808-Ljbffr AstraZeneca GmbH