Principal Medical Writer

Job Summary

A company is looking for a Principal Medical Writer (US or Canada).

Key Responsibilities

• Prepare summaries of nonclinical data for global regulatory submissions and support interactions with regulatory agencies
• Conduct scientific reviews to ensure data quality and integrity, providing constructive feedback and initiating process reviews
• Mentor colleagues and train associate writing staff while managing multiple assignments and representing nonclinical writing perspectives in discussions

Required Qualifications

• Minimum of a first degree in life sciences; advanced degree (e.g., PhD or Masters) preferred
• 8+ years of regulatory/medical writing experience, including 3-5 years as a nonclinical writing project lead
• Thorough knowledge of the drug development process and ICH guidelines
• Excellent organizational and time management skills
• Strong command of written and spoken English