Senior Medical Writer – Impactful, Collaborative FSP

Syneos Health, Inc.; Milton (MA); On-site; USD 81,000 - 176,000; Full time

Benefits offered by this job

Company car or car allowance

Health benefits (Medical, Dental, Vis）

401k match

Employee Stock Purchase Plan

Bonus based on performance

Flexible PTO and sick time

Job summary

Syneos Health is seeking a Sr Medical Writer (FSP) in Milton, MA to lead the preparation of clinical and regulatory documents with minimal supervision. The role involves coordinating across departments, ensuring adherence to FDA/ICH guidelines, and mentoring junior writers to deliver high-quality manuscripts, study reports, and submissions.

You will interact with clients, manage timelines within budget, and contribute to internal process improvements while supporting a fast-paced drug

Qualifications

• 3-5 years of relevant experience in science, technical, or medical writing.
• Experience working in biopharmaceutical, device, or contract research organization industry.
• Strong understanding of FDA and ICH regulations and good publication practices.
• Excellent English grammar and AMA Manual of Style.

Responsibilities

• Leads the clear and accurate completion of medical writing deliverables across studies, coordinating activities within and across departments.
• Produces a wide range of documents (protocols, clinical study reports, investigator brochures, summaries, safety reports, NDA/eCTD submissions, manuscripts, abstracts, posters).
• Ensures regulatory compliance with ICH guidelines and SOPs, and manages budget and timelines.
• Coordinates reviews, mentors junior writers, and maintains client communications to resolve comments and ensure quality.

Job description

Syneos Health is seeking a Sr Medical Writer (FSP) in Milton, MA to lead the preparation of clinical and regulatory documents with minimal supervision. The role involves coordinating across departments, ensuring adherence to FDA/ICH guidelines, and mentoring junior writers to deliver high-quality manuscripts, study reports, and submissions.

You will interact with clients, manage timelines within budget, and contribute to internal process improvements while supporting a fast-paced drug