Senior Medical Writer: Regulatory Submissions Lead

Syneos Health, Inc.; Toronto; On-site; CAD 80,000 - 145,000; Full time

Job summary

A biopharmaceutical solutions organization located in Toronto is seeking a Principal Medical Writer. This role involves leading the completion of medical writing deliverables, managing activities for individual studies, and producing various scientific documents all aligned with regulatory standards. The ideal candidate should possess a relevant degree, 3-5 years of writing experience in a relevant industry, and excellent communication skills. The position offers competitive compensation and comprehensive benefits.

Benefits

Company car or allowance

Health (Medical, Dental and Vision)

401(k) with company match

Employee Stock Purchase Plan

Potential commission/bonus

Flexible paid time off and sick time

Qualifications

• 3–5 years of relevant experience in science, technical or medical writing.
• Experience in the biopharmaceutical, device or contract research organization industry.
• Strong understanding of FDA and ICH regulations and good publication practices.
• Extensive knowledge of English grammar; familiarity with AMA Manual of Style.

Responsibilities

• Lead completion of medical writing deliverables with clarity and accuracy.
• Manage medical writing activities for studies with minimal supervision.
• Produce study protocols, reports, and manuscripts adhering to regulatory standards.
• Coordinate quality and editorial reviews; act as a peer reviewer.
• Build relationships with clients and cross-functional teams.
• Mentor less experienced medical writers.

Skills

Presentation skills

Proofreading skills

Collaborative skills

Interpersonal skills

Project management

Time management

MS Office proficiency

Understanding of medical terminology

Clinical research principles

Education

Bachelor’s degree in a relevant discipline

Graduate degree (preferred)

Job description

A biopharmaceutical solutions organization located in Toronto is seeking a Principal Medical Writer. This role involves leading the completion of medical writing deliverables, managing activities for individual studies, and producing various scientific documents all aligned with regulatory standards. The ideal candidate should possess a relevant degree, 3-5 years of writing experience in a relevant industry, and excellent communication skills. The position offers competitive compensation and comprehensive benefits.