Remote Senior Principal Medical Writer – Regulatory

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

Benefits offered by this job

Company car or car allowance

Health benefits (Medical, Dental, and

401k match

Employee Stock Purchase Plan

Commissions/bonus eligibility

Flexible PTO and sick time

Job summary

Syneos Health is seeking a Sr. / Principal Medical Writer (Regulatory focus) for sponsor-dedicated roles across NA/CA/UK. You will lead regulatory writing deliverables, coordinate across departments, ensure compliance with ICH E3 and client templates, and mentor junior writers.

Remote work options with US/UK/Canada flexibility are available. The position requires at least 5 years leading regulatory writing, hands-on experience with CTD Modules, CSRs, and submissions, and strong project and

Qualifications

• Minimum of 5 years of lead regulatory writing experience.
• Lead writing experience must include protocols, submissions, CTD Modules 2.7.3 and 2.7.4, CSRs, IBs, and related documents.
• Strong project management skills and client-facing experience.
• Good time management and budgeting awareness.
• Process experience is a plus; remote work adaptable to US, UK, and Canada.

Responsibilities

• Leads the clear and accurate completion of medical writing deliverables across studies.
• Manages medical writing activities within and across departments with minimal supervision.
• Coordinates quality and editorial reviews and ensures appropriate source documentation.
• Serves as peer reviewer for internal team to ensure clarity and consistency.
• Interacts with clients and cross-functional teams to deliver writing deliverables.
• Mentors less experienced writers on complex projects.
• Develops deep topic expertise and stays current on regulatory guidance.
• Works within budgeted hours and communicates status to leadership.
• Performs other duties as assigned; minimal travel may be required (<25%).

Skills

Lead regulatory writing

Project management

Client management

Time management

Regulatory submissions

Job description

Syneos Health is seeking a Sr. / Principal Medical Writer (Regulatory focus) for sponsor-dedicated roles across NA/CA/UK. You will lead regulatory writing deliverables, coordinate across departments, ensure compliance with ICH E3 and client templates, and mentor junior writers.

Remote work options with US/UK/Canada flexibility are available. The position requires at least 5 years leading regulatory writing, hands-on experience with CTD Modules, CSRs, and submissions, and strong project and