Nonclinical Writer at VirtualVocations

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 ReportsLead projects independently, ensuring alignment with regulatory guidelines and scientific integrityCollaborate with cross-functional teams and interpret pharmacokinetics, pharmacology, and toxicology dataRequired Qualifications:BS or higher in pharmacology, toxicology, biology, chemistry, or a related field with relevant industry experienceKnowledge of GLP, ICH guidelines, and applicable regulatory requirements2+ years of experience in pharmaceutical regulatory nonclinical writingProficiency with MS Office applications and familiarity with clinical trial and pharmaceutical developmentBasic understanding of CROs and scientific/nonclinical data terminology