Sr. Medical Affairs Specialist

Responsibilities

• Develop and deliver medical responses to healthcare provider inquiries on a global scale, requiring knowledge of local regulations and customs, translations, and ***'s expansive line of products.
• Review 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.
• Cook up 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 ***'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 ***'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.

Qualifications

• Proven experience using best practices and knowledge of internal or external business issues to improve products or services.
• Experience solving complex problems by taking a new perspective on existing solutions.
• In-depth knowledge and experience of global Medical Affairs best practices related to communicating clinical information externally to healthcare professionals and internally to cross-functional partners is an asset.
• Conceptual and practical expertise on diabetes and diabetes technologies (e.g. automated insulin delivery systems and insulin pumps, continuous glucose monitor systems, data management systems) is desirable.
• Excellent written and verbal communication skills.
• History of strong clinical practice in industry and/or non-industry settings.
• Familiarity with global regulatory and healthcare compliance guidelines/policies.
• Skilled in medical communication towards diverse audience groups.
• Working knowledge of relevant software programs [e.g., Microsoft Office Suite, Adobe Products, Medical Communication tools (Medical Information data management system, promotional material review)].