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Scientific. Clinical. Software Engineering

Technical Writer

Edison-New Brunswick Metro Area, NJ

Job Type: Scientific Job Number: JN -022020-26462 Region: Edison-New Brunswick Metro Area

Job Description

CMC Technical Writer

  • 4 years of experience with CMC regulatory related activities. BS/BA or MS, or PhD, from an accredited school in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy or a related field).
  • The CMC Regulatory Technical Writer works closely with quality, manufacturing, regulatory, and technical staff from global locations
  • Author high quality Module 2 and 3 CMC regulatory submissions for development and post-approval dossiers in eCTD format. The CMC Regulatory Technical Writer also authors change controls, following change control procedures.
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