Remote Senior Medical Writer - Regulatory Submissions

1001 Syneos Health, LLC; North Carolina; Hybrid; USD 81,000 - 145,000; Full time

Benefits offered by this job

Company car/allowance

Health benefits (Medical, Dental, Vis)

401k match

Job summary

Syneos Health, a leading global biopharmaceutical solutions organization, seeks a Sponsor Dedicated Senior Medical Writer (Regulatory Submission Documents) for a US-remote role. You will drive protocol and protocol amendments writing, produce regulatory documents, and ensure alignment with ICH/E3 guidelines while managing quality and timelines.

You will collaborate with Clinical Scientists, data management, biostatistics, and regulatory affairs to deliver compliant submissions, and mentor junior

Qualifications

• 3-5 years of relevant experience in medical writing, with proven experience in protocol writing.
• Experience working in biopharmaceutical, device, or CRO industries.
• Strong understanding of FDA and ICH regulations and good publication practices.

Responsibilities

• Lead the completion of medical writing deliverables across studies with minimal supervision.
• Coordinate writing activities within and across departments and respond to client comments.
• Prepare documents such as protocols, protocol amendments, clinical study reports, and integrated summaries.
• Adhere to regulatory standards and SOPs, manage source documentation, and lead team reviews.

Skills

Medical writing

Protocol writing

FDA/ICH regulations

Tools

Veeva/CARA

Job description

Syneos Health, a leading global biopharmaceutical solutions organization, seeks a Sponsor Dedicated Senior Medical Writer (Regulatory Submission Documents) for a US-remote role. You will drive protocol and protocol amendments writing, produce regulatory documents, and ensure alignment with ICH/E3 guidelines while managing quality and timelines.

You will collaborate with Clinical Scientists, data management, biostatistics, and regulatory affairs to deliver compliant submissions, and mentor junior