Senior Medical Writer: Lead Clinical Documentation

Syneos Health, Inc.; Amsterdam; On-site; EUR 71,000 - 154,000; Full time

Benefits offered by this job

Company car/allowance

Health benefits

401k match

Employee stock purchase plan

Paid time off (PTO)

Paid sick time

Job summary

Syneos Health, Inc. is seeking a Senior Medical Writer (FSP) to lead medical writing deliverables in clinical development.

You will oversee documents such as protocols, CSRs, and IBs, coordinating with data management, statistics, regulatory affairs, and medical affairs to ensure accuracy and on-time delivery. The role requires experience in clinical document writing and an ability to mentor junior writers, with exposure to global submissions and ICH guidelines.

Responsibilities

• Leads clear and accurate medical writing deliverables across studies, coordinating activities within and across departments with minimal supervision.
• Manages medical writing activities for individual studies and resolves client comments.
• Produces documents including protocols, CSRs and IBs, study reports, NDAs and eCTD submissions.
• Ensures adherence to regulatory standards (ICH E3) and company templates, styles and processes.
• Acts as peer reviewer to ensure scientific content, clarity, and consistency.
• Mentors less experienced writers and contributes to internal process improvements.

Job description

Syneos Health, Inc. is seeking a Senior Medical Writer (FSP) to lead medical writing deliverables in clinical development.

You will oversee documents such as protocols, CSRs, and IBs, coordinating with data management, statistics, regulatory affairs, and medical affairs to ensure accuracy and on-time delivery. The role requires experience in clinical document writing and an ability to mentor junior writers, with exposure to global submissions and ICH guidelines.