Sr Manager Medical Affairs, Omnipod 5 Franchise (Remote/Flexible) (Finance)

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: Sr. 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 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 accountable for the Omnipod 5 System's clinical value story that will be communicated to regulatory bodies, payors, healthcare providers and end users around the world. Collaborating with cross-functional and regional teams, you will ensure product features, labeled indication, clinical messages and educational content meet the needs of target audiences. This position will require you to think critically, and act as a strategic medical leader.

Key Accountabilities:

• Lead the development and execution of the strategic medical plans, including evidence generation, data dissemination and HCP engagement activities that align with local regulatory, commercial and market access priorities within the Omnipod 5 portfolio.
• Develop and prepare medical go to market strategies and content for global downstream teams that include professional education programs, medical conference presentations, and other healthcare provider/customer engagements.
• Bring effective medical leadership and work collaboratively within the Omnipod 5 Franchise to independently advise and guide the strategic objectives and operational decisions impacting key Omnipod 5 projects.
• Act as a disease state expert, drawing on your experience and knowledge of diabetes management, established standards of care, published data and key opinion leader insights.
• Define cross-functional study objectives and support design of clinical study protocols that deliver data needed to support regulatory approval, market access and market adoption of the Omnipod 5 System.
• Engage closely with clinical validation teams (Clinical Affairs, Human Factors, User Experience) to formulate data to inform decision-making, confirmation of clinical outcomes, and confirmation of risk control effectiveness.
• 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 industry experts by engaging with regional counterparts, investigators, international key opinion leaders and advisory boards.
• Establish professional learning needs and define educational requirements that ensure safe and effective use of Omnipod 5 and related products.
• Identify resource needs necessary to support assigned projects to meet the business objectives
• Continually seek new opportunities to bring Medical Affairs value to the organization.
• Supervise and mentor Medical Affairs staff as appropriate.

Education and Experience:

Minimum requirements

• 10+ years of experience with medical affairs and/or medical strategy within medical device or pharmaceutical industry or related discipline or equivalent education.
• 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.

Preferred requirements

• Advanced degree with healthcare related certification (Registered Nurse, Registered Dietitian, PharmD, Certified Diabetes Care and Education Specialist,).

Skills and Competencies:

• Proven success 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 especially automated insulin delivery systems.
• Experience with designing research studies and interpreting data.
• Skilled in medical communication to diverse audience groups.
• Passion to contribute to healthy teams and strong cross-functional collaborations.
• Strong technical and business acumen.
• A clear understanding of the international 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

Physical Requirements (if applicable):

• Location: Remote, residence in North America preferred.
• Candidate must reside in Eastern Time Zone in US.
• Travel within U.S. and International up to 15% is required but will flex depending on business need.

NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired). #LI-Remote

Additional Information:
The US base salary range for this full-time position is $141,500.00 - $212,600.00. 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.

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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