Clinical Regulatory Writing Director

Job Summary

Leading clinical regulatory writing activities, the full-time Clinical Regulatory Writing Associate Director will author complex regulatory documents, interpret clinical data, and drive strategic communications for pharmaceutical drug development programs in a remote setting.

Key responsibilities

• Independently manage clinical regulatory writing activities across multiple drug development programs
• Author complex clinical-regulatory documents in compliance with regulatory, technical, and quality standards
• Lead strategic communications for clinical development and regulatory submission teams

Required qualifications

• Master's degree in Life Sciences or an appropriate scientific discipline required
• Significant medical writing experience in the pharmaceutical industry or CRO
• Knowledge of drug development across clinical development, launch, and lifecycle management
• Experience in clinical regulatory writing and complex regulatory document authoring
• Proficiency in developing Clinical Submission Communication Strategies (cSCS)