Principal Medical Writer - Regulatory Submission Documents

Principal Medical Writer - Regulatory Submission Documents

Updated: December 3, 2025
Location: Toronto, ON, Canada
Job : -OTHLOC-1510-2DR

Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating therapeutic delivery. This role supports our Clinical Development model by providing high‑quality medical writing deliverables that align with regulatory and client standards.

• Lead clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Manage medical writing activities for individual studies, coordinating across departments with minimal supervision.
• Produce a wide range of documents including study protocols, protocols amendments, reports, patient narratives, journal manuscripts, abstracts, posters and presentations for scientific meetings.
• Adhere to regulatory standards (e.g., ICH E3, FDA, ICH guidelines, company SOPs, validated templates and style guides).
• Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately.
• Act as a peer reviewer for the internal team to ensure scientific content, clarity and consistency.
• Review statistical analysis plans and table/figure/listing specifications for proper content, grammar and consistency.
• Build collaborative relationships with clients and cross‑functional teams such as data management, biostatistics, regulatory affairs and medical affairs.
• Perform online clinical literature searches and respect copyright requirements.
• Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff.
• Mentor and lead less experienced medical writers on complex projects.
• Develop deep expertise on key industry topics and regulatory requirements.
• Work within budget specifications for assigned projects.

• Bachelor’s degree in a relevant discipline with writing experience; graduate degree preferred.
• 3–5 years of relevant experience in science, technical or medical writing.
• Experience in the biopharmaceutical, device or contract research organization industry required.
• Strong understanding of FDA and ICH regulations, other regulatory guidelines, and good publication practices.
• Experience writing the document types listed above.
• Extensive knowledge of English grammar and clear communication skills; familiarity with AMA Manual of Style.

• Strong presentation, proofreading, collaborative and interpersonal skills.
• Strong project and time‑management skills.
• Proficiency in MS Office.
• Understanding of medical terminology, principles of clinical research and how to interpret and present complex clinical data.

Salary Range: $80,600.00 – $ (base range; actual salary varies by qualifications and experience)

Benefits may include a company car or allowance, Health (Medical, Dental and Vision), 401(k) with company match, Employee Stock Purchase Plan, potential commission/bonus, and flexible paid time off (PTO) and sick time. Eligibility for paid sick time is governed by applicable federal, state and municipal laws.

Tasks, duties and responsibilities are not exhaustive; the Company may assign additional duties at its discretion. Equivalent experience, skills or education may be considered. The Company complies with the Americans with Disabilities Act and provides reasonable accommodations as required.