Regulatory Oncology Lead Medical Writer

Syneos Health, Inc.; Toronto; On-site; CAD 157,000 - 291,000; Full time

Job summary

A 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. Candidates should have experience with regulatory standards and a relevant educational background, with competitive salary ranging from $114,000 to $210,900 based on qualifications and experience.

Benefits

Career Development Opportunities

Engaged Line Management

Total Rewards Program

Qualifications

• Experience in developing regulatory documents for global submissions.
• Strong project management experience in medical writing.
• Ability to mentor junior medical writing staff.

Responsibilities

• Develop regulatory documents for agencies globally.
• Manage medical writing projects and timelines.
• Participate in process improvement initiatives.

Skills

Mentoring Junior Staff

Regulatory Document Development

Project Management

Cross-Functional Collaboration

Education

Relevant Bachelor's Degree

Tools

Regulatory Submission Guidelines

Clinical Document Standards

Job description

A 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. Candidates should have experience with regulatory standards and a relevant educational background, with competitive salary ranging from $114,000 to $210,900 based on qualifications and experience.