CMC Writer

Paramus, NJ - USA

Monthly Salary: Not Disclosed

Posted on: 4 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Title: CMC Writer
Job Location: Paramus NJ
Job Type: Contract

Job Description:

Author and review CMC sections of regulatory submissions (IND NDA BLA MAA IMPD) in CTD/eCTD format.

Manage timelines and deliverables for CMC workstreams ensuring alignment with project goals.

Prepare and coordinate CMC documentation for AR DSUR and responses to regulatory authority questions.

Ensure compliance with FDA EMA and ICH guidelines and internal processes.

Collaborate with cross-functional teams to gather accurate technical information.

Identify and communicate potential regulatory risks; propose mitigation strategies.

Support process improvement initiatives for CMC submission workflows.

Job Title: CMC Writer Job Location: Paramus NJ Job Type: Contract Job Description: Author and review CMC sections of regulatory submissions (IND NDA BLA MAA IMPD) in CTD/eCTD format. Manage timelines and deliverables for CMC workstreams ensuring alignment with project goa...