Senior Medical Writer — Protocols, CSRs & IBs Lead

Syneos Health, Inc.; United States; Remote; USD 81,000 - 176,000; Full time

Benefits offered by this job

Health benefits (Medical, Dental, Vis

Company match 401k

Employee Stock Purchase Plan

Commissions/Bonus

Flexible PTO and sick time

Job summary

Syneos Health is seeking a Senior Medical Writer (FSP) with clinical document writing experience across protocols, CSRs, and IBs. The role leads medical writing deliverables, coordinates across departments, and ensures regulatory compliance.

You will mentor junior writers, manage client feedback, and contribute to efficient study documentation while adhering to ICH E3 and company templates. This position may involve cross-functional collaboration and occasional travel.

Qualifications

• Extensive clinical writing experience across protocols, CSRs and IBs.
• Ability to lead editorial reviews and manage client feedback.
• Strong regulatory knowledge including ICH E3 guidelines.

Responsibilities

• Lead medical writing deliverables and coordinate activities across departments.
• Prepare protocols, CSRs, IBs and related documents.
• Ensure compliance with regulatory standards and approved templates.
• Mentor junior writers and provide technical guidance.
• Manage client communications and incorporate feedback.

Skills

Medical writing

Leadership

Mentoring

Job description

Syneos Health is seeking a Senior Medical Writer (FSP) with clinical document writing experience across protocols, CSRs, and IBs. The role leads medical writing deliverables, coordinates across departments, and ensures regulatory compliance.

You will mentor junior writers, manage client feedback, and contribute to efficient study documentation while adhering to ICH E3 and company templates. This position may involve cross-functional collaboration and occasional travel.