Senior Medical Affairs Specialist - Global Medical Communications

December 18

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Diabetes Youth Families

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11 - 50 employees

Founded 1938

⚕️ Healthcare Insurance

🔧 Hardware

Description

• Responsible for the development and delivery of medical responses to healthcare providers’ off-label inquiries on a global scale; requiring knowledge of local regulations and customs, translations, and Insulet’s expansive line of products. • Responsible for reviewing the content of global clinical promotional materials to ensure they are medically and scientifically accurate, meet compliance standards, and adhere to all applicable regional regulations and industry guidelines on a global scale. • Strategize and inform the development of evidence generation plans to provide meaningful data and impact innovation, support expansion of claims and indications, and satisfy regulatory requirements. • Coordinate the implementation of data management systems with external vendors to ensure compliance standards are met and functionality is optimized. • Develop and execute data dissemination plans to effectively communicate the clinical value of Insulet’s line of products to both internal and external audiences, including healthcare providers, people with diabetes, investors, and regulatory bodies, to emphasize the value of Insulet’s line of products and inform clinical care. • Analyze evidence related to diabetes therapies, standards of care, and technologies to inform product development and commercial and regulatory strategies. • Collaborate with Clinical and Regulatory Affairs on the development of clinical summaries for regional regulatory submissions on a global scale. • Develop clinical quality standards by ensuring procedures reflect current practices and initiatives align with set standards on a global scale. • Strategize and execute plans for International, National, and local scientific conferences (e.g. presentations, reports, medical information booth). • Provide mentorship to Medical Affairs interns.

Requirements

• Bachelor’s degree or its foreign equivalent in a health-related field is required. • A post-secondary degree (e.g. Masters), healthcare credentials (e.g. RD, RN, PA, NP, PharmD), and/or certification in diabetes education (e.g. CDCES, CDE) is preferred. • 3 to 5 years of relevant experience in a clinical, industry, or research setting is required (doctorate-level education in lieu of some years of experience is acceptable). • 1-2+ years of experience in the Medical Affairs industry (pharmaceutical/medical device) is preferred. • Clinical or scientific background related to diabetes disease state and diabetes technologies (e.g. insulin pumps, continuous glucose monitors) is desirable. • Fluency in English and French or German is an asset, but not required.