CMC Writer

Job Summary

A company is looking for a CMC Writer for a 6-month contract role, working remotely up to 24 hours per week.

Key Responsibilities:

• Develop and manage Module 3 content for regulatory submissions
• Collaborate with subject-matter experts and contract manufacturing organizations
• Ensure all documentation meets regulatory standards and deadlines

Required Qualifications:

• Proficiency in CMC writing for both small- and large-molecule products
• Experience leading NDA and MAA submissions, including variations and supplements
• Strong coordination skills with global experts and external partners
• Ability to work independently and integrate quickly into projects