Job Title:                         Manager Medical Affairs, Omnipod 5 FranchiseDepartment:                   Medical AffairsManager/Supervisor:       Sr. Director Medical Affairs, Omnipod 5 Franchise Lead FLSA Status:                     Exempt <div></div>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 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:To expand access to Insulet’s life changing technology, it is crucial to advance our product features and continually grow our body of evidence to understand who, and how people with diabetes experience the clinical and quality of life benefits while using the Omnipod 5 System. In this unique role, you will report to the Sr. Director of Medical Affairs, Omnipod 5 Franchise, and be a key contributor to the Omnipod 5 System’s innovative product pipeline. Collaborating with cross-functional and regional teams, you will ensure new products, features and uses alleviate the management burden of diabetes and improve health outcomes. This position will require you to think critically, and act as a strategic medical leader.Key Accountabilities:<ul><li>Provide effective medical leadership and work collaboratively with the solutions-level Omnipod 5 Franchise teams to advise and guide the strategic objectives and operational decisions impacting global project implementation.</li><li>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.</li><li>Advise on medical risks related to discovered product defects and provide guidance on prioritization of fixes and post-market field actions. </li><li>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. </li><li>Engage with clinical validation teams (Clinical Affairs, Human Factors, User Experience) to assist in data formulation to inform decision-making, confirmation of clinical outcomes, and confirmation of risk control effectiveness.</li><li>Develop evidence generation strategies based on program objectives and cross functional inputs that result in data needed to support regulatory approval and commercial product claims. </li><li>Translate available data into meaningful and robust clinical value stories that summarize clinical product performance.</li><li>Gather and translate medical intelligence from key industry experts by engaging with the Medical Science Liaison team, investigators, and advisory boards. </li><li>Develop and prepare 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. </li><li>Establish professional learning needs and define educational requirements that ensure safe and effective use of Omnipod 5 and future products and features.   </li><li>Continually seek new opportunities to bring Medical Affairs value to the organization.</li></ul>Education and Experience:Minimum requirements<ul><li>At least 5 years of experience with medical affairs and/or medical strategy within medical device or pharmaceutical industry or related discipline.</li><li>2 or more years in clinical, industry, or research settings that specifically relate to the diabetes disease state and devices (i.e., automated insulin delivery, continuous glucose monitors) or equivalent combination of education and experience.  </li></ul>Preferred requirements<ul><li>Advanced degree with healthcare related certification (Registered Nurse, Registered Dietitian, PharmD, Certified Diabetes Care and Education Specialist,).</li></ul>Skills and Competencies: <ul><li>Proven success in Medical Affairs including development and implementation of medical strategies. </li><li>In-depth understanding of diabetes (type 1 and type 2) including disease pathophysiology, treatment options, risks, and outcomes</li><li>Advanced knowledge of diabetes technology especially automated insulin delivery systems.</li><li>Experience with research study methods and interpreting data. </li><li>Skilled in medical communication to diverse audience groups. </li><li>Passion to contribute to healthy teams and strong cross-functional collaborations.</li><li>Strong technical and business acumen. </li><li>A clear understanding of the international regulatory environment related to medical devices.</li><li>Able to thrive in a fast-paced, multitasking environment and effectively prioritize project timelines.</li><li>Self-driven and regularly meets or exceeds expectations.</li><li>Working knowledge of relevant software programs [e.g., Microsoft Office Suite, Adobe Products, Medical Communication tools (Medical Information CRM, Promotional Material Review), etc.)]</li><li>High ethical standards which apply to interactions with HCPs, payers, and industry representatives</li></ul>Physical Requirements (if applicable): <ul><li>Location: Hybrid, San Diego, CA, Acton, MA</li><li>Domestic and international travel based on need.</li></ul>NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 3x/week; may work remotely other days). #LI-Hybrid  Additional Information:The US base salary range for this full-time position is $131,400.00 - $197,100.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.<div>Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com. We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.<div><div><div><div><div><div><div>(<a href="https://www.eeoc.gov/poster" target="_blank">Know Your Rights</a>)</div></div></div></div></div></div></div></div>