Nonclinical Writer

Job Summary

A company is looking for a Nonclinical Writer to develop, write, and manage technical nonclinical documents.

Key Responsibilities:

• Develop and write nonclinical documents such as eCTD submission documents and study reports
• Lead projects independently, ensuring alignment with regulatory guidelines and scientific integrity
• Collaborate with cross-functional teams and interpret pharmacokinetics, pharmacology, and toxicology data

Required Qualifications:

• BS or higher in pharmacology, toxicology, biology, chemistry, or a related field
• 2+ years of experience in pharmaceutical regulatory nonclinical writing
• Knowledge of GLP, ICH guidelines, and regulatory requirements
• Proficiency with MS Office applications
• Hands-on experience with clinical trial and pharmaceutical development preferred