Senior Medical Writer - Regulatory Docs (CSR, Protocols)

1001 Syneos Health, LLC; United States; Remote; USD 81,000 - 176,000; Full time

Benefits offered by this job

Company car

Health benefits

401k match

Job summary

Syneos Health is seeking a Sponsor Dedicated - Senior Medical Writer to lead regulatory documents for North America or EMEA. You will produce CSRs, protocols, IBs, and related submissions, ensuring accuracy, clarity and regulatory compliance across ICH/FDA guidelines.

You will mentor junior writers, coordinate with cross-functional teams, and manage timelines and budgets in a fast-paced environment. The role requires 3–5 years of medical writing experience in pharma/biotech, strong command of

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 GPP guidance.
• Experience writing regulatory documents (protocols, CSR, IB, NDA/eCTD).

Responsibilities

• Lead the completion of medical writing deliverables for studies with minimal supervision.
• Coordinate activities within and across departments and manage timelines.
• Lead client comment resolution and ensure high-quality, compliant documents.
• Mentor junior writers and contribute to internal writing standards.
• Ensure adherence to regulatory standards and formatting guidelines.

Skills

Medical writing

Regulatory documents

ICH guidelines

Editorial review

Mentoring

Client coordination

Job description

Syneos Health is seeking a Sponsor Dedicated - Senior Medical Writer to lead regulatory documents for North America or EMEA. You will produce CSRs, protocols, IBs, and related submissions, ensuring accuracy, clarity and regulatory compliance across ICH/FDA guidelines.

You will mentor junior writers, coordinate with cross-functional teams, and manage timelines and budgets in a fast-paced environment. The role requires 3–5 years of medical writing experience in pharma/biotech, strong command of