Manager Medical Affairs

• 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

• 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
• 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 automated insulin delivery systems
• Experience with designing research studies and interpreting data
• Skilled in medical communication to diverse audience groups
• Passion for working within a cross-functional team environment
• Strong technical and business acumen
• A clear understanding of the US and global regulatory environment related to medical devices
• Able to thrive in a fast-paced, multitasking environment and effectively prioritize project timelines
• Self-driven and regularly meets or exceeds expectations
• Working knowledge of relevant software programs [e.g., Microsoft Office Suite, Adobe Products, Medical Communication tools (Medical Information CRM, Promotional Material Review), etc.]
• High ethical standards which apply to interactions with HCPs, payers, and industry representatives

Advanced degree and/or healthcare related certification (PA/NP, Registered Nurse, Registered Dietitian, Certified Diabetes Care and Education Specialist, PharmD)

• Medical, dental, vision, life, disability, and other insurance plans
• ESPP (employee stock purchase program)
• 401K program with company match after 12 months
• HSA (Health Savings Account on the HDHP plan)
• SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions
• Corporate discount savings program
• On-demand training program
• Access to certification prep and a library of technical and leadership courses/books/seminars after 6+ months
• Certification discounts and other perks to associations that include CompTIA and IIBA
• Dedicated customer service team
• Certified Career Coach