Senior Medical Writer – Regulatory
Updated: December 15, 2025
Location: Canada (Remote)
Job ID: 25104251
Employment Type: Full-Time
Industry: Clinical Research / Regulatory Affairs / Medical Writing
About Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success. By combining clinical development, medical affairs, and commercial expertise, Syneos Health delivers meaningful outcomes that address evolving global healthcare challenges. With operations across more than 110 countries and a workforce of over 29,000 professionals, the organization supports innovation throughout the entire product lifecycle.
At Syneos Health, the Clinical Development model places both the customer and patient at the center of every activity. The company fosters an agile, collaborative, and inclusive work culture that empowers professionals to contribute to the delivery of life-changing therapies worldwide.
Position Summary
Syneos Health is seeking an experienced Senior Medical Writer – Regulatory to lead and manage high-quality regulatory and clinical writing deliverables. This role requires strong expertise in global regulatory standards, advanced scientific writing skills, and the ability to work cross-functionally with minimal supervision. The successful candidate will contribute to complex clinical development programs while ensuring compliance with international regulatory guidelines.
Key Responsibilities
Lead the preparation, review, and finalization of regulatory and clinical documents with a high level of scientific accuracy and clarity.
Manage medical writing activities for assigned studies, coordinating deliverables across departments and resolving client comments independently.
Author and review a wide range of documents including, but not limited to:
Clinical study protocols and protocol amendments
Clinical study reports (CSRs)
Patient narratives
Investigator brochures
Informed consent forms
Annual reports and clinical development plans
Plain language summaries
Periodic safety update reports (PSURs)
IND submissions, NDA submissions, and eCTD modules
Integrated summaries of safety and efficacy
Journal manuscripts, abstracts, posters, and scientific presentations
Ensure strict adherence to ICH guidelines (including ICH E3), regulatory authority requirements, company SOPs, and approved templates.
Coordinate quality control, editorial reviews, and document review meetings.
Serve as a peer reviewer to ensure scientific integrity, consistency, formatting accuracy, and regulatory compliance.
Review statistical analysis plans and TFL specifications, providing feedback to optimize document alignment and clarity.
Collaborate effectively with clinical operations, biostatistics, data management, regulatory affairs, and medical affairs teams.
Conduct clinical literature searches and ensure compliance with copyright regulations.
Identify risks and proactively propose solutions, escalating issues as appropriate.
Provide mentorship, technical guidance, and training to junior medical writers on complex projects.
Contribute to internal process improvements, best practices, and capability development initiatives.
Manage assigned project budgets and timelines, communicating progress to medical writing leadership.
Complete all administrative and compliance-related tasks within defined timelines.
Perform additional duties as assigned; minimal travel may be required (less than 25%).
Required Qualifications and Experience
Advanced degree in Life Sciences, Pharmacy, Medicine, or a related scientific discipline (PhD, MD, PharmD, or MSc preferred).
Minimum 6–8 years of experience in medical writing within a CRO, pharmaceutical, or biotechnology environment.
Demonstrated experience in regulatory medical writing, including submissions to FDA, EMA, and other global health authorities.
Strong working knowledge of ICH guidelines, regulatory frameworks, and clinical research processes.
Proven ability to manage multiple projects independently while meeting deadlines and quality standards.
Excellent written and verbal communication skills in English.
Strong attention to detail, analytical thinking, and problem-solving skills.
Why Join Syneos Health
Syneos Health offers a supportive and growth-oriented work environment where professionals can thrive and advance their careers. The organization is committed to continuous learning, diversity, equity, and inclusion, and provides access to technical training, leadership development, and global collaboration opportunities.
Compensation and Benefits
Competitive compensation package (salary based on qualifications, skills, and experience).
Comprehensive health benefits including medical, dental, and vision coverage.
Company-matched retirement plans.
Performance-based bonus or incentive eligibility.
Flexible paid time off and sick leave in compliance with local regulations.
Employee stock purchase program eligibility (where applicable).
Company Impact
Over the past five years, Syneos Health has supported:
94% of all novel FDA-approved drugs
95% of EMA-authorized products
More than 200 clinical studies across 73,000 sites
Over 675,000 clinical trial patients globally
Equal Opportunity Statement
Syneos Health is an equal opportunity employer committed to building a diverse, inclusive, and authentic workplace. Equivalent experience and transferable skills may be considered. Reasonable accommodations are provided in accordance with applicable laws.
How to Apply
Interested candidates are encouraged to apply through the official application process or join the Syneos Health Talent Network to stay informed about future opportunities.
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