- Provide effective medical leadership and work collaboratively within the solutions-level Omnipod 5 Franchise to advise and guide the strategic objectives and operational decisions impacting global project implementation.
- 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.
- Develop evidence generations strategies based 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.
- 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.
- Establish professional learning needs and define educational requirements that ensure safe and effective use of Omnipod 5 and related products.
- Life science degree with 5+ years of experience with medical affairs and/or medical strategy within medical device or pharmaceutical industry or related discipline.
- 2+ 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.
- Advanced degree and/or healthcare related certification (PhD, PharmD, Registered Nurse, Registered Dietitian, Certified Diabetes Care and Education Specialist).
- 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
- Location: Hybrid or remote position. Travel within North America and internationally will be required, up to 15% of the time depending on location.
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Manager, Medical Affairs - Acton, United States - Insulet Corporation
Description
Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.
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
Job Title: Manager Medical Affairs, Omnipod 5 Franchise
Department: Medical Affairs
Manager/Supervisor: Sr. Director Medical Affairs, Omnipod 5 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 Sr. Director Medical Affairs, Omnipod 5 Franchise Lead, this newly created Medical Affairs manager position will be a key contributing member of the Omnipod 5 cross-functional (Franchise) team to guide and influence the development of robust business plans and strategies that drive the global growth of specific Omnipod 5 initiatives. You will function as the Medical Affairs project lead and have accountabilities for all medical activities related to focused Omnipod 5 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 5 in current and future markets.
Key Accountabilities:
Minimum requirements
Additional Information:
The US base salary range for this full-time position is $109, $164, 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.
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.
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