Senior Medical Writer: Regulatory Submissions Lead

Syneos Health, Inc.; British Columbia; On-site; CAD 111,000 - 200,000; Full time

Job summary

A leading biopharmaceutical solutions organization in Canada seeks a Principal Medical Writer to ensure clear and accurate completion of regulatory submission documents. The ideal candidate will have 3-5 years of relevant writing experience in the biopharmaceutical field and a strong understanding of FDA and ICH regulations. This role involves managing medical writing activities, mentoring less experienced writers, and adhering to regulatory standards. Competitive salary range from $80,600 to $145,000 based on qualifications.

Benefits

Health benefits (Medical, Dental and Vision)

Company match 401k

Flexible paid time off (PTO)

Employee Stock Purchase Plan

Commission/bonus eligibility

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.

Responsibilities

• Lead the completion of medical writing deliverables ensuring accuracy.
• Manage medical writing activities with minimal supervision.
• Complete a variety of documents including clinical study protocols.

Skills

Strong presentation

Proofreading

Collaborative skills

Interpersonal skills

Project management

Time management

MS Office proficiency

Understanding of medical terminology

Education

Bachelor's degree in a relevant discipline

Graduate degree preferred

Tools

MS Office

Job description

A leading biopharmaceutical solutions organization in Canada seeks a Principal Medical Writer to ensure clear and accurate completion of regulatory submission documents. The ideal candidate will have 3-5 years of relevant writing experience in the biopharmaceutical field and a strong understanding of FDA and ICH regulations. This role involves managing medical writing activities, mentoring less experienced writers, and adhering to regulatory standards. Competitive salary range from $80,600 to $145,000 based on qualifications.