Senior Regulatory Medical Writer: Lead & Mentorship (Remote)

1001 Syneos Health, LLC; Canada; Remote; CAD 110,000 - 150,000; Full time

Job summary

Syneos Health in Canada seeks a Senior/Principal Medical Writer (Regulatory) to lead regulatory writing deliverables for sponsor-dedicated programs. You will coordinate studies, ensure compliance with ICH guidelines, and mentor junior writers.

You will interact with clients and cross-functional teams, manage timelines and budgets, and contribute to CTD modules, protocols, CSRs, and regulatory submissions. Remote work options available across US, UK, and Canada.

Qualifications

• Minimum of 5 years of lead regulatory writing experience.
• Lead writing experience with Phase 2 and 3.
• Experience with protocols, submissions, and CTD Modules (2.7.3/2.7.4), CSRs, IBs and related documents.
• Strong project and client management skills.
• Remote – Open to US, UK and Canada.

Responsibilities

• Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Manages medical writing activities across studies with minimal supervision and coordinates reviews and client feedback.
• Produces documents including protocols, CSRs, IBs, patient narratives, safety reports and regulatory submissions.
• Adheres to regulatory standards and company templates, with on-time delivery and budget respect.
• Mentors less experienced writers and contributes to internal process improvements.
• Interacts with clients and cross-functional teams to deliver writing deliverables.
• Performs literature searches and ensures copyright compliance.
• Monitors budgets and timelines; communicates status to leadership.

Skills

Regulatory writing

Lead writer

Project management

Client management

Time management

Detail oriented

Job description

Syneos Health in Canada seeks a Senior/Principal Medical Writer (Regulatory) to lead regulatory writing deliverables for sponsor-dedicated programs. You will coordinate studies, ensure compliance with ICH guidelines, and mentor junior writers.

You will interact with clients and cross-functional teams, manage timelines and budgets, and contribute to CTD modules, protocols, CSRs, and regulatory submissions. Remote work options available across US, UK, and Canada.