Where you come in
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.
Travel Required
5 - 15%
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.
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
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.
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.
Salary
$100,700.00 - $167,900.00
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