Remote Senior Principal Regulatory Medical Writer

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

Benefits offered by this job

Company car/allowance

Health benefits

401k match

Stock Purchase Plan

Bonuses

Paid time off

Job summary

Syneos Health, Inc. is seeking a Sr. / Principal Medical Writer (Regulatory focus) to lead regulatory writing deliverables for sponsor-dedicated projects across NA/CAN/UK, with potential remote work in the US and Canada.

You will drive clinical documentation, ensure compliance with ICH E3 and regulatory standards, and mentor junior writers in a collaborative, fast-paced environment. This role requires 5+ years of lead regulatory writing experience, strong project management, and client-facing

Qualifications

• Minimum of 5 years of lead regulatory writing experience.
• Lead writing experience must have.
• Experience with Phase 2 and 3.
• Lead writer experience with protocols, submissions, CSRs, IBs, and related documents.
• Strong project management skills.
• Strong client experience.
• Time management skills a must.

Responsibilities

• Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Manages medical writing activities associated with individual studies, coordinating with departments with minimal supervision.
• Leads the resolution of client comments.
• Completes a variety of documents including protocols, CSRs, IBs, safety reports, and summaries.
• Adheres to regulatory standards (ICH E3) and SOPs, templates, and style guides.
• Coordinates quality and editorial reviews and ensures proper source documentation.

Skills

Lead regulatory writing

Project management

Client experience

Time management

Job description

Syneos Health, Inc. is seeking a Sr. / Principal Medical Writer (Regulatory focus) to lead regulatory writing deliverables for sponsor-dedicated projects across NA/CAN/UK, with potential remote work in the US and Canada.

You will drive clinical documentation, ensure compliance with ICH E3 and regulatory standards, and mentor junior writers in a collaborative, fast-paced environment. This role requires 5+ years of lead regulatory writing experience, strong project management, and client-facing