Senior Medical Writer - Regulatory Submissions

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

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