Manager, Medical Affairs, Omnipod 5 Franchise (Remote)

Insulet Corporation•Acton, MA

79d•Remote

About The 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.

Requirements

At least 5 years of experience with medical affairs and/or medical strategy within medical device or pharmaceutical industry or related discipline.
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.
Proven success in Medical Affairs including development and implementation of medical strategies.
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 research study methods 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

Nice To Haves

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

Responsibilities

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.
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.
Advise on medical risks related to discovered product defects and provide guidance on prioritization of fixes and post-market field actions.
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 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.
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.
Translate available data into meaningful and robust clinical value stories that summarize clinical product performance.
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 future products and features.
Continually seek new opportunities to bring Medical Affairs value to the organization.