Nonclinical Writer

A company is looking for a Nonclinical Writer to participate in the development, writing, and management of highly technical nonclinical documents.

Key Responsibilities :

Develop and write nonclinical documents such as Module 2.4 and 2.6 eCTD submissions, Investigator's Brochures, and Nonclinical 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 with relevant industry experience

Knowledge of GLP, ICH guidelines, and applicable regulatory requirements

2+ years of experience in pharmaceutical regulatory nonclinical writing

Proficiency with MS Office applications and familiarity with clinical trial and pharmaceutical development

Basic understanding of CROs and scientific / nonclinical data terminology