Technical Writer (Remote), CMC Writer - Regulatory Affairs

Raleigh - NC

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Job Description

Pharmaceutical company with a drug / device combo product looking for a Technical Writer.CMC Writer, Regulatory Affairs:
 
  • Preparation of CMC regulatory submissions and associated activities, including review/approval of change requests, and other Quality Systems related CMC documentation
  • Experience in writing CMC components of regulatory submissions together with knowledge of relevant regulatory agency guidance including ICH, FDA, EMA, and authorities in other major geographic areas is desirable
  • Perform CMC technical writing and editing assignments related to the preparation of CMC components of regulatory submissions and other technical documents such as protocols, reports, eCTD sections of a NDA [Module 2 (QOS – DS and DP), Module 3], briefing packages, and procedures, as well as any other documents determined to be within the scope of the role; and ensure that project time-lines are met.
 

Skills & Requirements

 

 

  • 3+ years in pharmaceutical/medical device or industry related experience 
  • 3+ years in pharmaceutical/medical device or industry related experience ears in Regulatory Affairs or related experience
  • Knowledge of Drug development process; direct experience with IND or NDA approval process and direct interaction with FDA. Knowledge of GMPs, GDPs, etc