Principal Medical Writer
2 weeks ago
Principal Medical Writer - Regulatory Submission Documents Updated: December 3, 2025Location: Toronto, ON, CanadaJob ID: -OTHLOC-1510-2DR Description 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. Job Responsibilities 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. Qualifications 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. Necessary Skills 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. Benefits and Compensation Salary Range: $80,600.00 – $145,000.00 (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. Additional Information 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. #J-18808-Ljbffr
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Remote Principal Medical Writer, Oncology
5 days ago
Toronto, Canada Syneos Health, Inc. Full timeA leading biopharmaceutical solutions organization is seeking a Principal Medical Writer in Toronto, ON. This remote-based position involves developing regulatory documents for submissions to global agencies. The candidate will manage projects while ensuring high-quality and timely delivery of documents that meet program goals and regulatory requirements....
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Remote Principal Medical Writer, Oncology
2 weeks ago
Toronto, Canada Syneos Health, Inc. Full timeA leading biopharmaceutical solutions organization is seeking a Principal Medical Writer in Toronto, ON. This remote-based position involves developing regulatory documents for submissions to global agencies. The candidate will manage projects while ensuring high-quality and timely delivery of documents that meet program goals and regulatory requirements....
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Remote Principal Medical Writer, Oncology
2 weeks ago
Toronto, Canada Syneos Health, Inc. Full timeA leading biopharmaceutical solutions organization is seeking a Principal Medical Writer in Toronto, ON. This remote-based position involves developing regulatory documents for submissions to global agencies. The candidate will manage projects while ensuring high-quality and timely delivery of documents that meet program goals and regulatory requirements....
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Senior Principal Medical Writer
2 weeks ago
Toronto, Canada Syneos Health, Inc. Full timeSenior Principal Medical Writer - Regulatory - Oncology - Single Sponsor Updated: October 2, 2025Location: Toronto, ON, Canada Description Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique...
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Senior Principal Medical Writer
2 weeks ago
Toronto, Canada Syneos Health, Inc. Full timeSenior Principal Medical Writer - Regulatory - Oncology - Single Sponsor Updated: October 2, 2025 Location: Toronto, ON, Canada Description Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate...
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Senior Principal Medical Writer
2 weeks ago
Toronto, Canada Syneos Health, Inc. Full timeSenior Principal Medical Writer - Regulatory - Oncology - Single Sponsor Updated: October 2, 2025Location: Toronto, ON, Canada Description Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique...
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Principal Medical Writer
5 days ago
Toronto, Canada Syneos Health, Inc. Full timePrincipal Medical Writer - Regulatory Submission Documents Updated: December 3, 2025Location: Toronto, ON, CanadaJob ID: 25100455-OTHLOC-1510-2DR Description 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...
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Principal Medical Writer
2 weeks ago
Toronto, Canada Syneos Health, Inc. Full timePrincipal Medical Writer - Regulatory Submission Documents Updated: December 3, 2025 Location: Toronto, ON, Canada Job ID: 25100455-OTHLOC-1510-2DR Description Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating therapeutic delivery. This role supports our Clinical Development model by providing...
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Regulatory Oncology Lead Medical Writer
2 weeks ago
Toronto, Canada Syneos Health, Inc. Full timeA leading biopharmaceutical solutions organization located in Toronto is seeking a Senior Principal Medical Writer to develop and manage regulatory documents for submissions to authorities globally. This role requires strong project management skills, the ability to mentor junior writers, and collaboration across teams to ensure quality and compliance....
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Regulatory Oncology Lead Medical Writer
2 weeks ago
Toronto, Canada Syneos Health, Inc. Full timeA leading biopharmaceutical solutions organization located in Toronto is seeking a Senior Principal Medical Writer to develop and manage regulatory documents for submissions to authorities globally. This role requires strong project management skills, the ability to mentor junior writers, and collaboration across teams to ensure quality and compliance....
