Principal Medical Writer - Publications

Updated: May 7, 2026 | Location: Toronto, ON, Canada | Job ID: 25103771

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.
• Completes a variety of documents, including 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 submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations for scientific meetings.
• Adheres to established regulatory standards (e.g., ICH E3 guidelines) and company SOPs, client standards, and approved templates, ensuring projects are on time and on budget.
• Coordinates quality and editorial reviews; ensures source documentation is managed appropriately; leads and reviews team documents as needed.
• Acts as peer reviewer to ensure scientific content, clarity, consistency, and formatting of documents.
• Reviews statistical analysis plans and table/figure/specifications for content, grammar, format, and consistency, and provides feedback on statistical outputs.
• 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, and provides technical support, training, and consultation to department staff.
• Mentors and leads less experienced medical writers on complex projects.
• Develops deep expertise on key topics and regulatory requirements affecting medical writing.
• Manages budget specifications for assigned projects and communicates status to leadership.
• Completes required administrative tasks within specified timeframes.
• Performs other work-related duties as assigned.
• Minimal travel may be required (less than 25%).

Qualifications

• 3-5 years of relevant experience in science, technical, or medical writing.
• Experience working in the biopharmaceutical, device, or contract research organization industry.
• Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices.
• Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style.
• Experience writing relevant medical documents such as clinical study reports, investigator brochures, and regulatory submissions.

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate.