Medical Affairs Specialist

About the Company

Job Title: Sr. Medical Affairs Specialist

Start Date: ASAP

Duration: 6 months

Work Location / Logistics: Hybrid – 3 days onsite per week in Acton, MA

About the Role

Position Summary The Sr. Medical Affairs Specialist will report to the Senior Manager of Medical Affairs, Global Medical Communications. This role will leverage clinical, scientific, and disease-state expertise to support initiatives that communicate the clinical value of Omnipod’s scientific data and product portfolio. This position will work closely with Clinical, Commercial, Regulatory, and other cross-functional teams to help shape corporate strategy, support evidence dissemination, and communicate the appropriate clinical use and value of the company’s diabetes technology products. The ideal candidate will have strong experience in diabetes care, diabetes technologies, medical communications, clinical evidence interpretation, and global Medical Affairs practices. Experience with insulin pumps, automated insulin delivery systems, continuous glucose monitoring systems, and medical information processes is strongly preferred.

Responsibilities

Key Responsibilities

• Develop and deliver medical responses to healthcare providers’ off-label inquiries on a global scale.
• Ensure responses to medical information requests align with local regulations, regional requirements, translations, cultural considerations, and the company’s product portfolio.
• Review global clinical promotional materials to ensure content is medically and scientifically accurate, compliant, and aligned with applicable regional regulations and industry guidelines.
• Support the development and execution of evidence generation plans to provide meaningful clinical data, support innovation, expand claims and indications, and meet regulatory requirements.
• Coordinate with external vendors on the implementation and optimization of data management systems while ensuring compliance standards are met.
• Develop and execute data dissemination plans to communicate the clinical value of the company’s products to internal and external audiences.
• Communicate scientific and clinical information to healthcare providers, people with diabetes, investors, regulatory bodies, and internal stakeholders.
• Analyze evidence related to diabetes therapies, standards of care, and diabetes technologies to support product development, commercial strategy, and regulatory strategy.
• Collaborate with Clinical and Regulatory Affairs teams to develop clinical summaries for regional and global regulatory submissions.
• Support the development of clinical quality standards by ensuring procedures reflect current practices and initiatives align with established standards.
• Strategize and execute plans for international, national, and local scientific conferences, including presentations, reports, and medical information booth support.
• Provide mentorship and guidance to Medical Affairs interns.
• Work cross-functionally to ensure the clinical value of the Omnipod product line is communicated accurately, compliantly, and effectively.

Responsibilities – Key Decision Rights

Key Decision Rights

• Collaborate with cross-functional teams to ensure clinical value is communicated internally and externally in a scientifically accurate and compliant manner.
• Interpret business issues and recommend best practices for delivering global off-label medical information to healthcare providers through the Medical Information channel.
• Support strategic decisions related to medical communications, evidence dissemination, and clinical data interpretation.
• Help ensure medical content and clinical communications meet global regulatory and compliance requirements.

Required Skills

Required Skills and Competencies

• Strong experience in Medical Affairs, Medical Communications, Medical Information, Clinical Affairs, or related functions.
• Ability to interpret clinical evidence and translate key insights for diverse audiences.
• Strong understanding of global Medical Affairs best practices related to communicating clinical information externally to healthcare professionals and internally to cross-functional teams.
• Experience reviewing clinical promotional materials for medical accuracy, scientific validity, and compliance.
• Strong understanding of diabetes disease state and diabetes technologies is highly desirable.
• Experience with insulin pumps, automated insulin delivery systems, continuous glucose monitoring systems, and data management systems is strongly preferred.
• Familiarity with global regulatory requirements and healthcare compliance guidelines.
• Strong scientific writing, verbal communication, and presentation skills.
• Ability to solve complex problems and apply clinical judgment to business and scientific challenges.
• Ability to work independently with minimal guidance.
• Strong project management, organizational, and prioritization skills.
• High attention to detail and ability to complete accurate work within defined timelines.
• Ability to explain complex or sensitive scientific information clearly and professionally.
• Proficiency with Microsoft Office Suite, Adobe products, medical communication tools, medical information data management systems, and promotional material review platforms.

Preferred Skills

• Leadership and Interpersonal Skills
• Proven ability to lead and manage projects with cross-functional teams.
• Strong collaboration skills with the ability to work across global internal and external teams.
• Ability to operate effectively in a fast-paced, multitasking environment.
• Self-driven and proactive, with a hands-on and independent work style.
• Strong cross-cultural communication skills.
• Creative mindset with a desire to support innovation in diabetes technology.
• High ethical standards when interacting with healthcare providers, payers, industry representatives, and internal stakeholders.
• Ability to work cooperatively with Clinical, Commercial, Regulatory, Medical Affairs, and external partners.

Qualifications - Education and Experience

• Bachelor’s degree, or foreign equivalent, in a health-related field is required.
• Advanced degree such as a Master’s degree is preferred.
• Healthcare credentials such as RD, RN, PA, NP, PharmD, or similar are preferred.
• Diabetes education certification such as CDCES or CDE is preferred.
• 7–10 years of relevant experience in a clinical, industry, research, or related setting is required.
• Doctorate-level education may be considered in lieu of some years of experience.
• 4 years of global Medical Affairs experience within the pharmaceutical or medical device industry is preferred.
• Clinical or scientific background related to diabetes disease state and diabetes technologies is highly desirable.