Principal Medical Writer - Publications

Updated: January 17, 2026
Location: Toronto, ON, Canada
Job :

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Principal Medical Writer – Publications. This role involves writing and editing medical communications on clinical studies and regulatory submissions, including clinical study reports, patient narratives, safety updates, and manuscripts for publication.

• Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manage medical writing activities associated with individual studies, coordinating activities within and across departments with minimal supervision. Lead resolution of comments from the client.
• Complete a variety of documents such as clinical study protocols, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND, NDA, eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings.
• Adhere to established regulatory standards, including ICH E3 guidelines, company SOPs, client standards, and approved templates, authorship requirements and style guides, delivering projects on time and on budget.
• Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately. Lead team document reviews and provide peer reviews to ensure scientific content, clarity, consistency, and proper format.
• Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format and consistency. Provide feedback to define required statistical output and document needs.
• Interact and build good working relationships with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables.
• Perform online clinical literature searches and comply with copyright requirements.
• Identify and propose solutions to resolve issues, escalating as appropriate. Provide technical support, training, and consultation to department and company staff. Contribute to development of internal materials and improvements to internal processes and standard practices.
• Mentor and lead less experienced medical writers on complex projects.
• Develop deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing.
• Maintain awareness of budget specifications for assigned projects, working within budgeted hours and communicating status and changes to leadership.
• Complete required administrative tasks within specified time frames.
• Perform other work‑related duties as assigned.
• Minimal travel may be required (less than 25%).

• 3–5 years of relevant experience in science, technical, or medical writing.
• Experience working in the biopharmaceutical, device, or contract research organization industry required.
• Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required.
• Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with the AMA Manual of Style.
• Experience writing relevant document types required.

All qualified applicants will receive equal consideration for employment and will be provided reasonable accommodation when needed. The Company is committed to compliance with the Americans with Disabilities Act and the implementation of the EU Equality Directive.