Contract CMC Writer

Job Summary

Supporting client submission teams on a project-by-project basis, the remote Contract CMC Writer will lead the development of CMC content for INDs and nonclinical components of NDAs and BLAs, focusing on eCTD Modules 2 and 3.

Key responsibilities

• Lead authorship of CMC portions within Modules 2 and 3
• Work within Acumen and client eCTD templates to ensure consistency and submission readiness
• Partner with client SMEs to shape content, structure, and key messaging

Required qualifications

• Advanced degree (PhD, PharmD, MS, or equivalent) in a relevant scientific discipline
• Demonstrated experience in CMC regulatory writing
• Proven track record contributing to eCTD Modules 2 and 3
• Experience supporting IND, NDA, and/or BLA submissions
• Ability to translate complex data into clear, concise, submission-ready content