Senior Medical Writer - Clinical Solutions Lead

Syneos Health, Inc.; United States; On-site; USD 90,000 - 150,000; Full time

Job summary

Syneos Health, Inc. is seeking a Sr Medical Writer (FSP) to lead the preparation of medical writing deliverables across studies, ensuring clear and accurate scientific communication.

You will coordinate activities with cross-functional teams, adhere to ICH and FDA guidelines, and mentor junior writers to build expertise. In this role, you'll manage timelines, budget considerations, and client interactions, delivering high-quality documentation for clinical study protocols, reports, and

Qualifications

• 3–5 years of relevant experience in science, technical, or medical writing.
• Experience in biopharmaceutical, device, or CRO industry.
• Strong understanding of FDA and ICH regulations and good publication practices.

Responsibilities

• Lead the completion of medical writing deliverables with clear, accurate scientific information.
• Coordinate writing activities across departments with minimal supervision.
• Mentor less experienced writers on complex projects.
• Ensure regulatory compliance and adherence to SOPs and templates.
• Review and edit documents for content, formatting, and consistency.
• Manage budgeted hours and communicate status to leadership.
• Support clients and internal stakeholders to deliver writing deliverables.

Skills

Medical writing

Regulatory knowledge

Clinical study documentation

Job description

Syneos Health, Inc. is seeking a Sr Medical Writer (FSP) to lead the preparation of medical writing deliverables across studies, ensuring clear and accurate scientific communication.

You will coordinate activities with cross-functional teams, adhere to ICH and FDA guidelines, and mentor junior writers to build expertise. In this role, you'll manage timelines, budget considerations, and client interactions, delivering high-quality documentation for clinical study protocols, reports, and