Nonclinical Writer

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