Manager of Nonclinical Writing

Job Summary

To support early development and regulatory submissions, the hybrid Manager of Nonclinical Writing will lead nonclinical writing assignments, manage document processes, and collaborate with scientific teams while ensuring high-quality submission content.

Key responsibilities

• Lead nonclinical writing assignments and document preparation for regulatory submissions, including protocols and reports
• Coordinate review cycles for nonclinical documents and manage outsourced writing staff and projects
• Develop and maintain timelines for document generation and provide training on writing requirements and processes

Required qualifications

• Bachelor's degree in Life Sciences with 4+ years of relevant experience; professional certification and regulatory submission experience are a plus
• In-depth knowledge of Good Laboratory Practices, FDA regulations, and ICH guidelines
• Proven ability to manage multiple projects in a fast-paced environment
• Proficiency in Microsoft Suite and experience with electronic document management systems