Senior Regulatory Submissions Writer - Flexible PTO & Benefits

Syneos Health, Inc.; United States; On-site; USD 70,000 - 145,000; Full time

Job summary

Syneos Health is seeking a Senior Regulatory Submissions Writer to lead medical writing deliverables across studies, ensuring clear, compliant content and timely delivery.

You will collaborate across departments, mentor junior writers, and ensure adherence to ICH guidelines, EMA/FDA requirements, and AMA style, with limited travel (<25%). This role supports our Clinical Solutions team and client needs.

Qualifications

• 3-5 years of relevant experience in regulatory writing.
• Experience in the biopharmaceutical, device, or contract research organization industry.
• Strong understanding of EMA, FDA and ICH regulations, other regulatory guidelines, and/or good publication practices.
• Extensive knowledge of English grammar and AMA Manual of Style.

Responsibilities

• Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Manages medical writing activities associated with individual studies, coordinating across departments with minimal supervision.
• Leads the resolution of client comments.
• Completes documents including clinical study protocols, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, PSURs, CLDs, IND submissions, NDA/eCTD submissions, manuscripts, abstracts, posters, and presentations.

Skills

Regulatory writing

EMA/FDA/ICH regulations

English grammar

Job description

Syneos Health is seeking a Senior Regulatory Submissions Writer to lead medical writing deliverables across studies, ensuring clear, compliant content and timely delivery.

You will collaborate across departments, mentor junior writers, and ensure adherence to ICH guidelines, EMA/FDA requirements, and AMA style, with limited travel (<25%). This role supports our Clinical Solutions team and client needs.