Sr Medical Writer

1 DexCom Inc; California; Hybrid; USD 101,000 - 168,000; Full time

Job summary

Dexcom, Inc. in the United States seeks an experienced medical writer to lead authorship and lifecycle maintenance of clinical study reports, CERs, CEPs, PMCF plans, and related regulatory deliverables.

You will collaborate with Clinical Science, Biostatistics, Regulatory Affairs, and Quality to ensure scientifically accurate, regulator‑ready documents. You will design literature searches, manage timelines, and support FDA/other authorities questions, ensuring compliance with EU MDR, FDA

Qualifications

• Bachelor's degree and a minimum 5 - 8 years of related experience.
• Experience independently authoring and leading complex clinical and regulatory documents.
• Background in the medical device, biotechnology, or pharmaceutical industry.
• Strong scientific judgment and ability to translate evidence into clear narratives.

Responsibilities

• Lead authorship and lifecycle maintenance of clinical study reports and CERs.
• Develop CEPs, PMCF plans and evaluation reports with diverse data inputs.
• Design and document literature searches and evidence tables with traceable outputs.
• Collaborate with cross‑functional teams to ensure accuracy and regulatory alignment.
• Manage timelines, reviews, approvals, and version control for regulated documents.
• Support inspection‑readiness and document‑quality processes and templates.

Skills

Clinical writing

Regulatory submissions

Literature review

Cross-functional teamwork

Project management

Regulatory knowledge

Education

Bachelor's degree

Tools

EndNote

DistillerSR

Cloud PLM

Jama

Smartsheet

Jira

Job description

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:

The Clinical Medical Writing team is part of Dexcom’s Clinical organization and partners across Clinical Affairs, Biostatistics, Data Science, Regulatory Affairs, Quality, Medical Affairs, and Research and Development to translate clinical evidence into clear, accurate, and submission-ready documentation.

Where you come in:

In this role, you will lead the authorship and lifecycle maintenance of clinical study reports, clinical evaluation reports, and other clinical deliverables that communicate study results and support global regulatory submissions.

• You will lead the planning, authoring, review, finalization, and lifecycle maintenance of clinical study reports that accurately document clinical study methods, analyses, results, conclusions, and limitations.
• You will author and maintain clinical evaluation plans (CEPs), clinical evaluation reports (CERs), post-market clinical follow-up (PMCF) plans and evaluation reports, and supporting clinical evaluation deliverables, incorporating clinical investigation data, published literature, post-market information, risk-management inputs, and product documentation, as applicable.
• You will design, document, execute, and maintain systematic and targeted literature searches, including search strategies, screening criteria, evidence tables, and traceable outputs supporting CEPs, CERs, PMCF activities, regulatory submissions, and publications.
• You will develop and update clinical study protocols, protocol amendments, clinical summaries, benefit-risk documentation, responses to FDA and other regulatory-authority questions, notified-body responses, publications, and other clinical and scientific deliverables needed for global regulatory submissions and interactions.
• You will collaborate with Clinical Science, Clinical Program Management, Biostatistics, Data Science, Regulatory Affairs, Quality, Medical Affairs, and other subject‑matter experts to ensure documents are scientifically accurate, internally consistent, traceable, and aligned with approved source information.
• You will interpret clinical study data, statistical outputs, tables, listings, figures, protocols, and analysis plans and translate complex information into clear, concise, and audience‑appropriate scientific narratives.
• You will manage document timelines, authoring plans, review cycles, comment resolution, approvals, and version control while identifying and communicating risks to delivery.
• You will support inspection‑and‑audit‑ready documentation practices and contribute to medical writing procedures, templates, style standards, document‑quality checks, and continuous process improvement.
• You will apply relevant global medical‑device requirements and guidance to assigned deliverables, including Regulation (EU) 2017/745 (EU MDR), MEDDEV 2.7/1 Rev. 4, ISO 14155, applicable U.S. FDA requirements and guidance, Good Clinical Practice, and other regional regulatory expectations.

What makes you successful:

• You have demonstrated experience independently authoring and leading complex clinical and regulatory documents, particularly clinical study reports and clinical evaluation reports, within the medical device, biotechnology, or pharmaceutical industry.
• You understand clinical research methodology, medical‑device development, Good Clinical Practice, scientific interpretation, and the relationship among protocols, statistical analysis plans, clinical data, risk‑management documentation, and regulatory submissions.
• You bring strong scientific judgment and can evaluate source information, identify inconsistencies or evidence gaps, and work with subject‑matter experts to reach clear, well‑supported conclusions.
• You write with clarity, precision, consistency, and appropriate context and can tailor technical content for regulators, clinicians, scientists, and cross‑functional stakeholders.
• You are skilled at leading cross‑functional document teams, facilitating review and comment resolution, managing multiple priorities, and delivering high‑quality work to established timelines in a matrixed organization.
• You have strong working knowledge of Microsoft Word and experience using EndNote, DistillerSR, Cloud PLM, Jama, Smartsheet, and Jira, or comparable reference‑management, systematic‑literature‑review, electronic document‑management, requirements‑management, and project‑management systems.
• You have experience with continuous glucose monitoring, diabetes, digital health, or other regulated medical‑device technologies is preferred.
• You have working knowledge of Regulation (EU) 2017/745 (EU MDR), MEDDEV 2.7/1 Rev. 4, ISO 14155, applicable U.S. FDA requirements and guidance, Good Clinical Practice, and global clinical evaluation and regulatory‑documentation expectations.

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 on a global scale.
• 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.

Experience and Education Requirements:

Typically requires a Bachelor's degree and a minimum 5 - 8 years of related experience.

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.

Travel Required:

5 - 15%

Salary:

Salary: $100,700.00 - $167,900.00 #DexcomUS

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 [e-mail].

AI in Hiring Notice: We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.

At Dexcom, we're more than just a medical device company; we're a collective of visionary thinkers, trailblazers, and problem solvers. Our mission transcends the ordinary. We aim to revolutionize healthcare, one groundbreaking technology at a time.