Sr. Medical Writer (Regulatory)

Syneos Health, Inc.; Toronto; On-site; CAD 100,000 - 125,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Senior Medical Writer in Toronto, Ontario. This role involves leading the completion of regulatory documents, ensuring clarity and compliance with established guidelines. The candidate will manage writing activities, conduct quality reviews, and mentor less experienced writers. Benefits include health coverage, a 401k match, stock purchase eligibility, and flexible paid time off. The estimated salary range varies based on qualifications and experience.

Benefits

Company car or car allowance

Health benefits (medical, dental, vision)

401k company match

Employee Stock Purchase Plan

Flexible paid time off

Qualifications

• Proven experience in medical writing and regulatory documentation.
• Strong attention to detail and ability to adhere to deadlines.
• Experience in mentoring less experienced writers.

Responsibilities

• Lead and complete medical writing deliverables accurately.
• Ensure compliance with regulatory standards and templates.
• Coordinate and conduct quality and editorial reviews.

Skills

Medical writing

Client relationship management

Regulatory compliance

Technical support

Mentoring

Job description

Updated: December 15, 2025
Location: Toronto, ON, Canada
Job ID:25104251-OTHLOC-1510-2DR

Sr. Medical Writer (Regulatory)

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.

Job 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 activities within and across departments with minimal supervision. Leads the resolution of comments from the client.
• Completes a variety of documents that may include clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations for scientific meetings.
• Adheres to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides, delivering projects on time and on budget.
• Coordinates quality and editorial reviews, manages source documentation, leads team document reviews, and performs peer reviews to ensure scientific content, clarity, consistency, and proper format.
• Reviews statistical analysis plans, table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to define statistical output and document needs.
• Interacts and builds relationships with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce deliverables.
• Performs online clinical literature searches and complies with copyright requirements.
• Identifies and proposes solutions to resolve issues, escalates as appropriate, provides technical support, training, and consultation to department and other staff, and may contribute to internal materials and process improvements.
• Mentors and leads less experienced medical writers on complex projects.
• Develops deep expertise on key topics and regulatory requirements that affect medical writing.
• Works within budgeted hours, communicates status and changes to leadership, completes required administrative tasks, performs other duties, and may travel less than 25%.

Benefits

The benefits for this position may include a company car or car allowance, health benefits (medical, dental, vision), company match 401k, eligibility to participate in Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on performance, and flexible paid time off (PTO) and sick time.

Salary Range

$0.00 - $0.00 (Base salary range represents anticipated low and high of the Syneos Health range; actual salary varies based on qualifications and experience.)

Additional Information

Tasks, duties, and responsibilities listed are not exhaustive. The company may assign other tasks. The company is committed to compliance with the Americans with Disabilities Act and provides reasonable accommodations. The company complies with all applicable paid sick time requirements.