Remote Senior Medical Writer: Protocols, CSRs & IBs

Syneos Health, Inc.; New Hampshire; Hybrid; USD 81,000 - 176,000; Full time

Benefits offered by this job

Company car/allowance

Health benefits: medical, dental, and视

401k match

Employee Stock Purchase Plan

Commissions/bonus

Flexible PTO and sick time

Job summary

Syneos Health, Inc. is seeking a Senior Medical Writer for a remote, global role focusing on clinical document writing experience (Protocols, CSRs and IBs).

The position supports our Clinical Solutions team across multiple time zones, delivering high-quality documents under regulatory standards. You will lead medical writing activities, mentor junior writers, ensure adherence to ICH E3 and company templates, and coordinate with data management, biostatistics and regulatory affairs to meet study

Qualifications

• Proven experience in clinical writing for protocols, CSRs and IBs.
• Ability to coordinate cross-functional teams with investigators, data management and regulatory affairs.
• Knowledge of ICH E3 guidelines and regulatory standards.

Responsibilities

• Lead the timely completion of medical writing deliverables across studies.
• Prepare protocols, CSRs, IBs and related documents.
• Ensure regulatory compliance with ICH E3 and SOPs.
• Coordinate quality reviews and client feedback.
• Mentor junior medical writers on complex projects.
• Manage budgets and timelines for writing projects.
• Communicate with cross-functional teams and clients.
• Stay current with regulatory guidelines in clinical writing.

Skills

Medical writing

Clinical documents

Protocols

CSRs

IBs

Job description

Syneos Health, Inc. is seeking a Senior Medical Writer for a remote, global role focusing on clinical document writing experience (Protocols, CSRs and IBs).

The position supports our Clinical Solutions team across multiple time zones, delivering high-quality documents under regulatory standards. You will lead medical writing activities, mentor junior writers, ensure adherence to ICH E3 and company templates, and coordinate with data management, biostatistics and regulatory affairs to meet study