Senior Medical Writer — Clinical Documentation Lead

Syneos Health/ inVentiv Health Commercial LLC; Missouri; On-site; USD 81,000 - 176,000; Full time

Benefits offered by this job

Company car or car allowance

Health benefits

401k match

Employee Stock Purchase Plan

Bonus based on performance

Job summary

Syneos Health is seeking a Senior Medical Writer (FSP) for clinical document writing across protocols, CSRs and IBs. You will lead the preparation of scientific documents, ensuring accuracy, regulatory compliance, and timely delivery.

The role involves mentoring junior writers, coordinating with data management, biostatistics, regulatory affairs, and external clients, and maintaining quality across documents while adhering to budgets and SOPs.

Qualifications

• Experience composing clinical study protocols, CSRs and IBs.
• Proficient with ICH E3 guidelines and regulatory standards.
• Ability to mentor junior medical writers.

Responsibilities

• Lead clear, accurate medical writing deliverables for studies.
• Coordinate writing activities with cross-functional teams.
• Review client comments and drive resolution.
• Ensure compliance with SOPs, templates and style guides.
• Mentor less experienced writers.
• Perform online literature searches and manage copyright.

Skills

Medical writing

Regulatory standards

Mentoring

Job description

Syneos Health is seeking a Senior Medical Writer (FSP) for clinical document writing across protocols, CSRs and IBs. You will lead the preparation of scientific documents, ensuring accuracy, regulatory compliance, and timely delivery.

The role involves mentoring junior writers, coordinating with data management, biostatistics, regulatory affairs, and external clients, and maintaining quality across documents while adhering to budgets and SOPs.