Senior Medical Writer - Clinical Solutions Lead

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

Job summary

Syneos Health, Inc. is seeking a Sr Medical Writer (FSP) in the Boston area to lead medical writing deliverables and coordinate cross-functional activities. You will prepare a range of regulatory and scientific documents and ensure compliance with ICH/FDA guidelines and AMA style.

The role emphasizes collaboration with clients and internal teams, mentoring junior writers, and staying within budget and timelines, with limited travel up to 25%.

Qualifications

• 3–5 years of relevant experience in science, technical, or medical writing.
• Experience in the biopharmaceutical, device, or contract research organization industry.
• Strong understanding of FDA and ICH regulations, and good publication practices.
• Experience writing relevant document types.
• Excellent English grammar with AMA style familiarity.

Responsibilities

• Leads clear and accurate medical writing deliverables and coordinates activities.
• Produces documents such as protocols, reports, narratives, consent forms, posters and manuscripts.
• Ensures regulatory standards, on-time and on-budget delivery.
• Coordinates quality reviews and manages source documentation.
• Mentors less experienced writers and develops topic expertise.
• Maintains client relationships and communicates status and budget constraints.
• Performs literature searches and supports internal process improvements.
• Minimal travel may be required (<25%).

Skills

Medical writing

Regulatory knowledge

Editorial oversight

Job description

Syneos Health, Inc. is seeking a Sr Medical Writer (FSP) in the Boston area to lead medical writing deliverables and coordinate cross-functional activities. You will prepare a range of regulatory and scientific documents and ensure compliance with ICH/FDA guidelines and AMA style.

The role emphasizes collaboration with clients and internal teams, mentoring junior writers, and staying within budget and timelines, with limited travel up to 25%.