Senior Nonclinical Writer
Job Summary
Participating in the development, writing, and management of highly technical nonclinical documents, the full-time Senior Nonclinical Writer will work remotely to lead the writing of submission documents for regulatory approvals while ensuring alignment with current guidelines and scientific integrity.
Key responsibilities:
- Lead the writing and management of nonclinical submission documents for INDs/CTAs/NDAs/BLAs/MAAs with minimal oversight
- Interpret and analyze pharmacokinetics, pharmacology, and toxicology data to support document development
- Collaborate with cross-functional teams to ensure nonclinical packages meet regulatory guidelines and sponsor requirements
Required qualifications:
- BS or higher in pharmacology, toxicology, biology, chemistry, or a related field with industry experience in regulatory writing
- 5+ years of experience in pharmaceutical regulatory nonclinical writing
- Strong understanding of GLP, ICH guidelines, and regulatory requirements
- Proficiency in MS Office applications and familiarity with clinical trial and pharmaceutical development
- Basic understanding of CROs and scientific/nonclinical data terminology
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