Share Email Opening Title Associate Director, Medical Affairs  About the Organization kaléo is a new type of pharmaceutical company, dedicated to building innovative solutions for serious and life-threatening medical conditions.   Description PURPOSE, OBJECTIVES, FUNCTIONS:This role serves as a subject matter expert (SME) within kaléo’s Medical Affairs team. Primary functions include medical communications, education, grants and publications. The Associate Director is responsible for successful execution of Medical Affairs deliverables, utilizing collaborative relationships across kaléo to ensure compliance with applicable kaléo policies and government regulations. This is a Richmond, VA headquarters-based role responsible for execution of kaléo's Medical Affairs functions including medical education, communications, grants and publications. Primary Functions: Collaborate with cross-functional subject matter experts (SMEs) to design and implement internal and external education materials using scientifically-accurate and relevant content tailored to learner needs; manage materials through kaléo’s review process to ensure internal and government standards for scientific exchange Manage unsolicited medical information requests escalated to Medical Affairs by kaléo’s call center through direct response to requestors or triage to Medical Science field teams Author standard response letters to address common, unsolicited healthcare provider inquiries, supported by scientifically sound data and references Serve on kaléo’s grant committee to evaluate unsolicited educational or research grant requests for appropriateness based on alignment with kaléo’s scientific objectives, advancement of scientific knowledge, and program soundness Author, co-author or collaborate on kaléo-led or sponsored publications, including but not limited to peer-reviewed manuscripts, articles and materials for congress activities, in accordance with GPP3, ICMJE, COPE and journal (if applicable) standards Oversee kaléo’s scientific resource library to enable Medical Affairs access and archive of current literature related to kaléo’s products and associated therapeutic areas Monitor new literature and alert and/or review with Medical Affairs staff as appropriate to ensure awareness and understanding Serve as secondary Medical reviewer as needed for kaléo’s Review Committee and Medical Review Team to ensure timely review of materials intended for internal or external audiences Conduct reviews utilizing a validated, electronic platform Collaborate with cross-functional stakeholders to provide scientific expertise in support of key business initiatives Represent Medical Affairs at cross-functional team meetings as required Manage and execute appropriate Medical Affairs projects as required   Open Date 8/7/2018   Position Requirements Advanced scientific or healthcare degree or significant healthcare professional experience and 8+ years of relevant pharmaceutical industry experience. An advanced degree such as an MD, PharmD, PhD is preferred. Strong familiarity with medical terminology, clinical trial design and statistics Strong experience in development of medical education materials including research and design with consideration of scientific accuracy and adult learning principles Proven technical writing experience including authorship of clinical reports, economic value summaries, meta analyses, and/or peer-reviewed publications Ability to engage and build relationships with external thought leaders on collaborative projects• Ability to understand and synthesize large amounts of clinical, scientific, technical, and medical information, summarizing data to draw a conclusion Working knowledge of copyright regulations and publication standards including but not limited to GPP3, ICJME and CORE Working knowledge of FDA guidance on advertising and promotion of prescription drug and medical devices (in particular, 21 CFR parts 201 and 202), safe harbor, scientific exchange and PhRMA code   Exempt/Non-Exempt Exempt   Full-Time/Part-Time Full-Time   EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.   Location Corporate   This position is currently not accepting applications. To search for an open position, please go to http://KaleoPharma.appone.com WE ALSO RECOMMEND Other Jobs Within Same Category -- None found -- Other Jobs Within 60 Miles -- None found -- Follow us See who works here:

 

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