CMC Writer
CMC Writer requires:
oPrior experience in pharmaceutical or regulatory writing.
oCMC (Chemistry, Manufacturing, and Controls) Writer experience.
oBachelor's or advanced degree in chemistry, pharmaceutical sciences, or a related field
oCMC Writer, Chemistry, Manufacturing, and Controls, Regulatory, Drug Development, Manufacturing, and Quality Control, NDA/MAA CTD, EU (IMPD and MAA), US-FDA, FDA, IND, BLA, NDA, eCTD, Project Management, Pharmaceutical
oFamiliar with eCTD format submission files
oProject management skill is plus CMC Writer duties:
oRegulatory Documentation: Author and review CMC sections of regulatory submissions, including IND, NDA, and MAA applications.
oCompliance & Guidelines: Ensure documents align with FDA, EMA, and ICH regulatory requirements.
oCollaboration: Work closely with scientists, regulatory affairs teams, and manufacturing experts to gather accurate data.
oQuality Assurance: Maintain consistency, clarity, and accuracy in technical writing.
oProcess Improvement: Help establish regulatory CMC submission processes and procedures.
Employment Type: Full-Time
Salary: $ 49.00 Per Hour
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