Technical Writer- CMC

Company Name:
Biobridges, LLC
PROJECT DETAILS:
Write and/or review CMC sections of regulatory submissions (NDA, MAA, IND, Annual Reports) using CTD and eCTD format.
Help prepare submissions for regulatory filings.
Support, as needed, any additional regulatory or quality related writing projects.
REQUIREMENTS:
BS/BA degree, preferably in the pharmaceutical industry or related scientific field.
At least 4 years of experience in writing pharmaceutical development reports, regulatory writing or quality control/quality assurance.
Experience writing and reviewing module 3 CMC reports.
Understanding of regulatory CMC for solid oral dosage forms, including specification setting and method development.
Practical Formulation and Process Development experience to go along with strong regulatory and eCTD CMC authoring experience.
Ability to interpret and communicate FDA regulations, identify regulatory opportunities and risks, and propose resolutions to development issues.
Familiarity with cGMPs, Standard Operating Procedures, and FDA regulations.

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