Senior Medical Affairs Specialist

🕒 June 17

🇺🇸 United States – Remote

💵 $95.9k - $159.9k / year

⏰ Full Time

🟠 Senior

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Dexcom

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1999

⚕️ Healthcare Insurance

🧬 Biotechnology

Healthcare Insurance • Biotechnology • Wearable Technology

Dexcom is a leading provider of continuous glucose monitoring (CGM) systems, revolutionizing how people manage diabetes and track their glucose levels. Known for their best-in-class glucose biosensing technology, Dexcom offers products like the Dexcom G7 CGM system, which provides real-time glucose monitoring and insights to help individuals become healthier. Founded in 1999, Dexcom has consistently innovated in the field of diabetes management, empowering users to take control of their health with accurate and advanced glucose monitoring solutions. Their products are designed for both adults and children and do not require a prescription.

📋 Description

• You will effectively collaborate with project stakeholders to ensure full alignment of plan, timelines and expectations. • You will be adaptable to change, be very detail oriented and be able to critically analyze and interpret clinical studies for outcomes and clinical methodology. • You will establish Standard Operating Procedures and processes for Medical Affairs Team that require documentation and standardization within the promotional review and medical inquiry subfunctions. • You will collaborate with cross-functional teams to update and maintain existing product and marketing claims matrices through the Veeva Promotional Materials Review platform. • You will support the updates and adherence to a global promotional review process and claims development procedure that is consistent, yet keeping in mind the regional nuances that may impact claim generation and accuracy within North America and other English-speaking countries as needed. • You will provide medical and clinical review of advertising and promotional materials to ensure that the clinical data and medical terminology in promotional claims is accurate and referenced appropriately. • You will maintain current with the clinical literature regarding glucose management, diabetes, metabolic disease and CGM (i.e. emerging data and Standards of Care). • You will regularly review of key diabetes and technology journals with a proactive eye for bringing forward key clinical or product claims for Dexcom commercial utilization. • You will collaborate with global Medical and Clinical Affairs teams to identify key manuscripts and proactively work with cross-functional teams to develop new claims for inclusion in the product and/or outcome claims matrices. • You will support the Promotional Review Team and attend meetings for the development of new claims and ensure medical and clinical accuracy. • You will continuously assess the current claims development process and seek for efficiencies and opportunities for improvement within the Medical function of the full Medical, Legal and Regulatory review process. • You will clearly communicate changes needing to be made in promotional materials and the ‘why’ behind the changes to your commercial colleagues. • You will interaction with the Veeva Promotional Review software platform daily, to formally review and approve promotional materials. • You will stay current on US and Canadian regulatory body’s guidance on health and product claims creation and implementation (FDA and Health Canada). This may be required of other English-speaking countries as needed. • You will support the development of internal audit process of claims utilization in promotional materials and identify areas of opportunity for improvement; working closely with Regulatory and Legal team members involved with promotional review. • You will provide monthly key performance indicators and data on promotional review metrics. • You will create, manage and respond to medical inquiries within the US, Canada and other English-speaking countries from healthcare professionals as needed. • You will perform other tasks or projects as needed to support the medical affairs function.

🎯 Requirements

• Typically requires a Bachelor’s degree and a minimum of 5 – 8 years of related experience. • You will have a bachelor’s degree in a science-related field at minimum, with a clinical registration or licensure as RD, RN, PharmD, or advanced Degree (Masters or PhD) “or fellowship” in a science-related field. • You have strong knowledge of diabetes literature and of the management of diabetes. • You will be knowledgeable in the diabetes market and pharmaceutical and medical device industry within the US and Canada. • You will be well versed in clinical study methodology, scientific literature review and how it translates to promotional or medical claims. • You will have strong communication skills and working with Teams to gain alignment. • You are able to deal with ambiguity – ready to change gears and plans quickly. • You have a significant attention to detail for accuracy of content as well as grammar and spelling. • You are very organized and detail-oriented. • Your computer skills include Microsoft Office Suite - Word, Excel and PowerPoint; Adobe Acrobat Pro; Microsoft 365; Smart Sheets; Microsoft Copilot; Microsoft Teams. Experience with Veeva Promotional Materials and Medical Communications platforms is a plus.

🏖️ Benefits

• A full and comprehensive benefits program. • Growth opportunities within the arena of Medical Affairs. • Access to career development through in-house learning programs and/or qualified tuition reimbursement. • An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.