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We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed to protect and enhance life.
JOB SUMMARYThe Director, Medical Affairs will be an integral part of the Global Medical Affairs team. They will be responsible for providing scientific thought leadership and support across the medical affairs efforts in the opioid antidote therapeutic area. This will include supporting strategy in both US and ex-US as aligned medical engagement initiatives. Specific duties include strategy as a subject matter expert, leading Promotion Review Team for medical, coordinating Medical Information needs with our communications team and engaging with external experts as part of medical affairs strategy for publications/IIS/CME. This role will also serve as a training and scientific matter expertise for internal needs within the therapeutic area or brand.
ESSENTIAL FUNCTIONSReasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Serve as the subject matter expert to support therapeutic area priorities and growth strategies.Lead as the primary Medical Reviewer and Subject Matter Expert (SME) for Promotional Review Committee (PRC) and Medical Review Committee (MRC).Provide medical review of Promotional and Medical Affairs materials to ensure statements are scientifically accurate, truthful and non-misleading, and that promotional claims are adequately supported, including the appropriateness of references cited.Lead cross-functional teams (including Marketing, Regulatory Affairs, and Legal) to ensure collaborative outcomes on workstreams aligned to scientific strategy.Support/lead content development in collaboration with the Medical Communications team for Medical Information, Training related documents; with ability to submit documents into Veeva Vault as needed.Create, review, and maintain Medical Affairs scientific materials, scientific slide decks, and internal training/directive documents.Lead collaboration with Medical Communications to support Med Inquiries and engage in appropriate scientific exchange.Collaborate with Medical Affairs team members and external vendors/consultants to facilitate the development of content for specific identified goals aligned to strategy.Collaborate with Global Safety & Epidemiology, to provide support for data generation and any potential external communication tools (pubs, presentations).Provide training to internal business partners as needed on disease state or product.The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLSAdvanced scientific or clinical/medical degree required (MD, DO, PharmD, PhD).Experience in leading cross-functional teams within a complex matrix.Understanding of US business and Ex US needs to develop comprehensive support plans.5+ years of working experience within the pharmaceutical industry and 2+ years of professional experience in Medical Affairs is required.Lead promotional/medical review experience required.Prior experience in digital review systems is required; Veeva Vault and/or Veeva Med Comms is preferred.Prior experience in training/teaching.An established track record of facilitating effective high-quality medical communications.Strong organizational skills.Strong scientific acumen with the ability to translate and effectively communicate complex scientific data for varying audiences.Strong project management skills with a proven track record to deliver multiple projects in time and excellent quality.If the hiring manager expresses an interest in interviewing you for the open position, you must discuss your interest in the open position with your current manager prior to an interview being scheduled.
ABOUT EMERGENTProtecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.
Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.
WE BELIEVE IN OUR VALUES Lead with IntegrityWe gain trust and confidence through ethics, quality, and compliance excellence.Stand shoulder to shoulder no matter whatWe combine our best thinking and communicate openly to support each other.Own it alwaysEvery person at Emergent is engaged and accountable for delivering on our commitments.Break through thinkingWe take smart risks, pursue innovation and challenge ourselves to constantly improve.Compete where it countsWe set the right goals and respect each other as we conquer them together.
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