Manager, Technical Release Manager
1Password
SDLC
Manager, Medical Affairs, Omnipod 5 Franchise
Diabetes Youth Families
full-time
Posted on:
Location Type: Remote
Location: Remote • California, Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $131,400 - $197,100 per year
Job Level
Mid-LevelSenior
About the role
- 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
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 specifically related to the diabetes disease state and devices (i.e., automated insulin delivery, continuous glucose monitors)
- Advanced degree with healthcare-related certification (Registered Nurse, Registered Dietitian, PharmD, Certified Diabetes Care and Education Specialist)
- 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
- Working knowledge of relevant software programs [e.g., Microsoft Office Suite, Adobe Products, Medical Communication tools (Medical Information CRM, Promotional Material Review), etc.]
Benefits
- Flexible working arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical strategyclinical validationevidence generationdata interpretationrisk control measuresproduct design requirementsmedical go-to-market strategiesdiabetes technologyautomated insulin delivery systemscontinuous glucose monitors
Soft skills
collaborationleadershipcommunicationstrategic thinkingproblem-solvingdata formulationeducational needs assessmentengagement with key opinion leadersprofessional education developmentopportunity identification
Certifications
Registered NurseRegistered DietitianPharmDCertified Diabetes Care and Education Specialist
