Sr Medical Affairs Specialist

The Company

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.

Meet the team:

Dexcom’s Global Medical Affairs team is seeking an experienced medical affairs professional to join our team and be part of Dexcom’s award-winning culture, recognized by Fortune's Best Workplaces in Health Care & Biopharma. The Sr. Medical Affairs Specialist position in Global Medical Affairs is a key contributor to the success, effectiveness and efficiency of the Global Medical Affairs Team and our partnership with the Dexcom Commercial Teams. The Sr. Medical Affairs Specialist position is an individual contributor position within the Medical Affairs department focusing on medical guidance, review and approval of promotional materials developed by Dexcom’s Commercial Marketing Teams and also support for the medical inquiry sub-function of Medical Affairs as needed. This position will be a contributing member of the North American Promotional Material Review Team (PMRT) and the Global Medical Review Committee (MRC). This position interacts directly with all members of the Medical Affairs department and closely collaborates with the Regulatory, Marketing (consumer, HCP, international/global, and payer), Medical Writing, Scientific Communications, Clinical Affairs, Evidence Planning, and Legal teams on promotional copy review, new claim development, and ensuring the claims trace matrix is current, globally and regionally relevant. This position is responsible for the current review of CGM, biosensors, diabetes, and/or metabolic disease relevant literature and proactively bring key clinical evidence to the cross-functional claims development team to review and approve marketing claims and its accurate use in digital and collateral materials. This position will be remote, but living in the United States and will support the medical review of promotional materials for the United States, Canada and other English-speaking regions as required. Beyond core capabilities, we are seeking organized and detailed-oriented executers and problem solvers, passionate and collaborative teammates, and those willing to roll up their sleeves to make a difference. If you are interested in the opportunity to pursue purposeful work, join a mission-driven team, and build a rewarding career while having fun, Dexcom and the Medical Affairs team may be the perfect fit for you.

Where you come in:

• 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.

What makes you successful:

• You are results-oriented, self-disciplined, fast-paced, motivated individual.
• You deliver high quality work output and with great attention to detail.
• You require minimal supervision and able to multitask several projects at one time.
• 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 be able to critically analyze studies their strengths and limitations and assess the robustness of clinical study methodology.
• You will have strong communication skills and working with Teams to gain alignment
• You have working knowledge of document control software systems and document control processes within a pharmaceutical or medical device company.
• You are able to deal with ambiguity – ready to change gears and plans quickly.
• You are a strong communicator (oral/written), have a high level of business acumen and interpersonal skills.
• 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.
• You are adaptable and thrive under a complex and fast-paced working environment which makes you confident managing expectations from partners while balancing timely delivery of work projects.
• You are team-focused, and a strong collaborator yet can work independently.
• You apply problem-solving skills to identify new and innovative approaches to do work more efficiently and effectively.
• You must lead with Dexcom’s values in everything you do - Think Big, Be Dependable, Listen and Serve with Integrity.

What you’ll get:

• A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
• 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.

Travel Required:

• 15 - 25%

Experience and Education 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 science-related field at minimum, with a clinical registration or licensure as RD, RN, PharmD, or advanced Degree (Masters or PhD) “or fellowship” in science-related field.

Remote Workplace:

Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option.

Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at talentacquisition@dexcom.com.

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at talentacquisition@dexcom.com.

Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: [https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true](https://protect-us.mimecast.com/s/fufTCyPOPqFWlgBzhMXJ2t?domain=health1.meritain.com)

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