Sr. Principal Regulatory Medical Writer - Oncology

Sr. Principal Regulatory Medical Writer - Oncology Preferred

Updated: June 9, 2026

Location: Toronto, ON, Canada

Job : -OTHLOC-1510-2DR

Description

Senior Principal Regulatory Medical Writer – Oncology. The role will develop regulatory documents for submission to agencies globally, manage medical writing projects, collaborate with cross‑functional teams, review related documents, and handle eCTD submission activities.

Responsibilities

• Develop regulatory documents for submission to regulatory agencies globally—including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews—according to ICH and other global guidelines, standards, and processes.
• Manage medical writing projects, including developing timelines (working with study/project teams) and communicating with cross‑functional team members to maintain awareness of review cycles and expectations.
• Participate in cross‑functional meetings to provide input regarding medical writing deliverables, timelines, and any process needed for completion of regulatory documents.
• Review other documents associated with the assigned project(s) (e.g., Protocols and Statistical Analysis Plans).
• Preferred: eCTD submission experience.

Benefits

• Company car or car allowance
• Health benefits:
  
  Medical, Dental and Vision
• Company match 401(k)
• Employee Stock Purchase Plan eligibility
• Eligibility to earn commissions/bonus based on company and individual performance
• Flexible paid time off (PTO) and sick time

Salary Range: $95,000.00–$ – The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on qualifications, skills, competencies, and proficiency for the role.

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations when appropriate, and to maintaining compliance with the EU Equality Directive. The Company may assign additional tasks, duties, and responsibilities as needed.