Senior Medical Writer | Medical Devices & Regulatory Documents – Remote (Alaska, USA)
Location: Remote – Alaska, USA
Job ID: 25103632
Updated: December 3, 2025
Overview
Syneos Health®, a global leader in fully integrated biopharmaceutical solutions, is seeking a Senior Medical Writer specializing in medical devices and regulatory documentation. This remote role supports clinical and regulatory teams by producing high-quality scientific and regulatory content for submissions, publications, and internal communications.
Ideal candidates have advanced expertise in medical writing, regulatory documentation, and clinical communications, with strong attention to detail and the ability to manage multiple complex projects.
Key Responsibilities
Lead the creation, review, and finalization of medical writing deliverables, ensuring clarity, scientific accuracy, and compliance with regulatory standards.
Prepare a variety of documents including:
Clinical study protocols and amendments
Clinical study reports (CSRs)
Patient narratives and investigator brochures
Informed consent forms
Annual reports, plain language summaries, and periodic safety update reports
Clinical development plans, IND submissions, integrated summary reports, NDA/eCTD submissions
Manuscripts, abstracts, posters, and scientific presentations
Ensure compliance with ICH E3 guidelines, client standards, internal SOPs, templates, and style guides.
Coordinate quality and editorial reviews; manage source documentation and peer reviews for clarity, consistency, and scientific integrity.
Review statistical analysis plans and outputs to ensure accurate interpretation and presentation of study data.
Conduct systematic literature searches and summarize scientific findings in compliance with copyright regulations.
Mentor and guide junior medical writers on complex projects.
Collaborate with cross-functional teams including regulatory affairs, biostatistics, medical affairs, and clinical operations.
Track project progress, adhering to budgets, timelines, and company standards.
Provide technical support, process improvement recommendations, and training as required.
Minimal travel (<25%) may be required.
Required Qualifications
Advanced degree in life sciences, pharmacy, medicine, or related field preferred.
Extensive experience in medical writing for medical devices and regulatory submissions.
Strong knowledge of regulatory guidelines (FDA, EMA, ICH) and medical writing standards.
Demonstrated ability to manage multiple complex projects and meet deadlines.
Excellent written and verbal communication skills in English.
Strong attention to detail, analytical skills, and organizational capabilities.
Experience mentoring junior writers and performing peer reviews.
Compensation & Benefits
Salary Range: $80,600 – $145,000 (depending on experience and qualifications)
Health, dental, and vision coverage.
Company match 401(k) and Employee Stock Purchase Plan eligibility.
Flexible paid time off (PTO) and sick leave.
Career development opportunities within a globally recognized clinical research and medical writing organization.
About Syneos Health
29,000 employees across 110 countries.
Supported clinical trials for 94% of novel FDA-approved drugs and 95% of EMA-authorized products over the past 5 years.
Committed to diversity, inclusion, and employee development, fostering a culture where employees can thrive.
Summary:
The Senior Medical Writer (Remote – Alaska) produces regulatory, clinical, and scientific documents to support medical device development and submissions. This role ensures compliance, accuracy, and clarity of all medical writing deliverables while mentoring junior writers and collaborating with global cross-functional teams.
Apply now to join Syneos Health and contribute to innovative clinical research and medical communications on a global scale.
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