Dova is currently recruiting a Director, Medical Affairs to join our team in Durham, NC, reporting to the Vice President, Medical Affairs. In the role of Director, Medical Affairs, you will be responsible for managing all US Medical Information service functions, including but not limited to the medical review of promotional and scientific materials, and planning and implementation of medical information deliverables within set timelines.
To be successful in this role, you must provide accurate, timely, balanced and up-to-date medical and scientific information to internal and external customers. You will develop and maintain current, broad, and in-depth knowledge of pathophysiology, pharmacotherapy, and clinical outcomes of Dova products.
• Deliver high-quality, balanced and timely written and verbal medical information upon the request of health care professionals and consumers.
• Manage the Medical Information Call Center and serves as the escalation point for triage of complex inquiries from MI Call center.
• Develop/maintain current, broad, and in-depth knowledge of pathophysiology, pharmacotherapy, and clinical outcomes associated with Dova products and disease states.
• Develop and maintain up-to-date medical documents, including medical content letters, FAQs, Dossiers, etc.
• Represent medical function in the Promotional Review Committee (PRC) and ensure medical accuracy, relevance and completeness of data, appropriateness of references cited and that promotional claims within materials are adequately supported by data.
• Chair of the Medical Review Committee (MRC) and ensure medical accuracy of all non-promotional materials undergoing review.
• Provide medical expertise and oversight to commercial teams for appropriate disease and product claims development.
• Autonomously plan and facilitate disease, product, response document and process-related training of medical information contact center associates.
• Proactively distribute important product and/or medical information to relevant internal Medical Affairs functions as necessary in support of product changes, safety issues and other sentinel events; enhance medical and product knowledge within the Sales Force, Marketing, Field Medical and other departments by disseminating relevant information on a consistent basis, as needed.
• Systematically compile and communicate metrics to monitor Medical Information trends and able to apply these analytics to the medical plan.
• Provide support to broader activities in Medical Communications as necessary, including Medical Education and Scientific Communications.
• Ensure all policies, SOPs, work instructions, and guidance documents governing the practice of medical information up-to-date and meets all compliance standards.
• Achieve and maintain compliance with all applicable regulatory, legal and federal regulations
• Other duties as assigned.
• Medical or scientific degree is required (PharmD preferred).
• 5 – 7 years of related work experience is required.
• 2+ years of relevant experience in reviewing and/or editing promotional materials.
• Demonstrated project management skills (1-2 years).
• Highly proficient in literature searching skills.
• Highly detail-oriented in the development and review of medical information response documents.
• Excellent written and verbal communication skills.
• Self-motivated to drive for results, with strong organizational and planning skills.
• Highly proficient with Microsoft Office Suite.
• Knowledge of medical information best practices, legal, and regulatory requirements (Codes of Practice, Standard Operating Practices) and guidelines is preferred.
• Experience leading medical information initiatives for a product launch, including developing work practice documents, SOPs and effective training materials, preferred.
• Ability to travel for meetings/conferences approximately 20% of the time.
Why Join Us?
With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.
We know our employees are our most valuable asset, and our culture conveys that. At our Durham office, we provide a sleek and high-tech work environment with glass walls and adjustable desks. All employees are issued laptops, have access to a stocked kitchen, and are included in Free Lunch Fridays! We also offer a competitive benefits package, to support the health and happiness of our staff.