Senior Medical Writer - Regulatory & Submissions (Remote)

Syneos Health, Inc.; Remote; CAD 111,000 - 200,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Sr Medical Writer for a remote position, responsible for developing regulatory documents and ensuring adherence to guidelines. Candidates should have at least 5 years of medical writing experience, strong communication skills, and a thorough knowledge of regulatory processes. The role involves collaboration with multiple departments, leading document reviews, and mentoring junior writers. Competitive benefits including health coverage and performance bonuses are offered. Salary ranges from $80,600 to $145,000 based on qualifications.

Benefits

Health benefits including Medical, Dental and Vision

Company match 401k

Flexible paid time off (PTO)

Qualifications

• At least 5 years of experience in medical writing or regulatory documents.
• Strong knowledge of ICH E3 guidelines and related compliance.
• Proven ability to write clearly and coherently in a scientific manner.

Responsibilities

• Lead the completion of medical writing deliverables accurately.
• Manage various medical writing activities with minimal supervision.
• Review statistical analysis plans ensures grammar and consistency.

Skills

Medical writing

Regulatory standards adherence

Client interaction

Technical writing expertise

Team collaboration

Education

Bachelor's degree in Life Sciences or related field

Job description

A leading biopharmaceutical solutions organization is seeking a Sr Medical Writer for a remote position, responsible for developing regulatory documents and ensuring adherence to guidelines. Candidates should have at least 5 years of medical writing experience, strong communication skills, and a thorough knowledge of regulatory processes. The role involves collaboration with multiple departments, leading document reviews, and mentoring junior writers. Competitive benefits including health coverage and performance bonuses are offered. Salary ranges from $80,600 to $145,000 based on qualifications.