Manager, Medical Affairs T2D and Data Products Franchise (Remote)

Job Title: Manager Medical Affairs, Type 2/Data Products Franchise Department: Medical Affairs Manager/Supervisor: Director Medical Affairs, Type 2/Data Products Franchise Lead FLSA Status: Exempt Our Company Insulet Corporation is an innovative medical device company dedicated to simplifying the lives of people living with diabetes. Founded in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom, and healthier lives using our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of people living with diabetes by using innovative technology that is wearable, waterproof, and lifestyle accommodating. Insulet’s latest innovation, the Omnipod® 5 Automated Insulin Delivery System, is a tubeless automated insulin delivery system, integrated with a continuous glucose monitor to manage blood sugar with no need for daily injections, zero finger sticks, and is fully controlled by a compatible personal smartphone. The Company’s world headquarters and state-of-the-art automated manufacturing facility are located in Acton, Massachusetts with global offices in the U.K., France, Germany, Netherlands, Canada, Mexico, Australia, and the United Arab Emirates. Omnipod products are available in 24 countries around the world. Insulet’s Medical Affairs team adds to our innovation journey by providing medical expertise to the organization to inform research and development, evidence generation and dissemination, professional engagement, and medical education to advance our mission. This Position Reporting to the Director Medical Affairs, Type 2 / Data Products Franchise Lead, this newly created Medical Affairs manager position will be a key contributing member of the cross-functional (Franchise) team to guide and influence the development of robust business plans and strategies that drive the global growth of specific Omnipod initiatives. You will function as the Medical Affairs project lead and have accountabilities for all medical activities related to focused Omnipod projects throughout the full lifecycle (early development through end of life). You will be responsible for providing medical advisory and strategy that drive meaningful, safe, and effective innovation, impactful evidence, and effective knowledge translation to customers to expand the accessibility of Omnipod in current and future markets. Key Accountabilities

• Provide effective medical leadership and work collaboratively within your assigned project teams to advise and guide the strategic objectives and operational decisions impacting global project direction.
• Act as the medical expert, drawing on your experience and knowledge of diabetes management, established standards of care, published data and key opinion leader insights.
• Shape medically sound product design requirements, critically assess systems and user error risks, and advise on risk control measures that ensure safe and effective use.
• Engage closely with clinical validation teams (Clinical Affairs, Human Factors, User Experience) to formulate study needs, evaluate outcomes, and confirmation of risk control effectiveness.
• Inform evidence generation strategies based on program objectives and cross functional inputs that result data needed to support regulatory approval and competitive product claims.
• Translate available data into meaningful and robust insights and conclusions that support regulatory requirements, commercial claims, and product value messaging.
• Gather and translate medical intelligence from key industry experts by engaging with the Medical Science Liaison team, investigators, and advisory boards.
• Collaborate on medical go to market strategies and content for regional downstream teams that include professional education programs, medical conference presentations, and other healthcare provider/customer engagements.
• Support assessment of professional learning needs and educational requirements that ensure safe and effective use of Omnipod and related products. Education And Experience Minimum requirements
• 5+ years in clinical, industry, or research settings that specifically relate to the diabetes disease state and devices (i.e., insulin pumps, continuous glucose monitors) or equivalent combination of education and experience.
• Life science degree with 5+ years of experience with medical affairs and/or medical strategy within medical device or pharmaceutical industry or related discipline. Preferred Requirements
• Advanced degree and/or healthcare related certification (PA/NP, Registered Nurse, Registered Dietitian, Certified Diabetes Care and Education Specialist, PharmD). Skills And Competencies
• Proven experience in Medical Affairs including developing and leading the implementation of medical strategy. In-depth understanding of diabetes (type 1 and type 2) including disease pathophysiology, treatment options, risks, and outcomes Advanced knowledge of diabetes technology including automat

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