Job Number:
HC-04323
Date Posted:
April 2, 2026
Position Title:
Principal Medical Writer – Regulatory Submission Documents
Party:
N/A
Office Code:
Office/Company:
Syneos Health
Reports To:
Location:
Remote
Contact:
Salary:
$95,000.00 – $175,700.00
Primary Role
Secondary Role:
Job Type:
Full Time
Description:
Syneos Health is a leading fully integrated life sciences services organization built to accelerate customer success.Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.Bachelor’s degree in a relevant discipline with relevant writing experience; graduate degree preferred.
Responsibilities:
• Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision.
• Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings.
• Adhere to established regulatory standards, including ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style/formatting guides.
• Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately.
• Act as a peer reviewer for the internal team to ensure scientific content, clarity, consistency, and proper format.
Qualifications:
• Bachelor’s degree in a relevant discipline with relevant writing experience; graduate degree preferred.
• 3–5 years of relevant experience in science, technical, or medical writing.
• Experience working in the biopharmaceutical, device, or contract research organization industry required.
• Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required.
Instructions:
Email <ddress>
Other:
Syneos Health complies with all applicable federal, state, and municipal paid sick time requirements.
