Senior Medical Affairs Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• You will collaborate effectively with project stakeholders to ensure complete alignment of plans, timelines, and expectations.

• You will demonstrate adaptability to change, exhibit strong attention to detail, and possess the ability to critically analyze and interpret clinical studies for outcomes and methodologies.

• You will establish Standard Operating Procedures and processes for the Medical Affairs Team that require documentation and standardization within the promotional review and medical inquiry subfunctions.

• You will work alongside cross-functional teams to update and maintain existing product and marketing claims matrices through the Veeva Promotional Materials Review platform.

• You will assist in the updates and adherence to a global promotional review process and claims development procedure that is consistent, while also considering the regional nuances that may affect claim generation and accuracy in North America and other English-speaking countries as necessary.

• You will provide medical and clinical reviews of advertising and promotional materials to ensure that the clinical data and medical terminology in promotional claims are accurate and referenced appropriately.

• You will keep current with clinical literature regarding glucose management, diabetes, metabolic diseases, and CGM (including emerging data and Standards of Care).

• You will regularly review key diabetes and technology journals with a proactive focus on highlighting significant clinical or product claims for Dexcom commercial use.

• You will collaborate with global Medical and Clinical Affairs teams to identify key manuscripts and actively 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 participate in meetings for the development of new claims, ensuring medical and clinical accuracy.

• You will continuously evaluate the current claims development process and seek efficiencies and opportunities for enhancement within the Medical function of the overall Medical, Legal, and Regulatory review process.

• You will clearly communicate necessary changes in promotional materials and the rationale behind these changes to your commercial colleagues.

• You will engage daily with the Veeva Promotional Review software platform to formally review and approve promotional materials.

• You will remain informed about US and Canadian regulatory body guidance on health and product claims creation and implementation (FDA and Health Canada), which may also apply to other English-speaking countries as required.

• You will assist in developing an internal audit process for claims utilization in promotional materials and identify improvement opportunities, collaborating closely with Regulatory and Legal team members involved in promotional review.

• You will provide monthly key performance indicators and data on promotional review metrics.

• You will create, manage, and respond to medical inquiries from healthcare professionals in the US, Canada, and other English-speaking countries as necessary.

• You will perform additional tasks or projects as required 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 hold at least a bachelor's degree in a science-related field, accompanied by clinical registration or licensure as RD, RN, PharmD, or an advanced degree (Masters or PhD) “or fellowship” in a science-related discipline.

• You possess strong knowledge of diabetes literature and diabetes management.

• You will be familiar with the diabetes market and the pharmaceutical and medical device industries within the US and Canada.

• You are well-versed in clinical study methodology, scientific literature reviews, and their translation into promotional or medical claims.

• You have excellent communication skills and the ability to work collaboratively with teams to achieve alignment.

• You can navigate ambiguity and are prepared to adapt quickly to changing circumstances and plans.

• You exhibit significant attention to detail, ensuring the accuracy of content as well as grammar and spelling.

• You are highly organized and detail-oriented.

• Your computer skills encompass the Microsoft Office Suite - Word, Excel, and PowerPoint; Adobe Acrobat Pro; Microsoft 365; Smart Sheets; Microsoft Copilot; and 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 Medical Affairs arena.

• 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.