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CMC Technical Writer

Company: Beacon Hill Staffing Group - Pharma
Location: King Of Prussia
Posted on: January 12, 2018

Job Description:

The CMC Technical Writer needs IV/Oral (tablets) Dosing product experience and must have Module 2 and Module 3 Writing experience Provide regulatory assessment of post-approval CMC changes for assigned FDA approved NDA drug products in accordance with current FDA regulations and guidance; author and compile CMC dossiers for NDA supplements, annual reports, and DMF annual updates for assigned products in eCTD format. Work closely with quality, manufacturing, regulatory and technical staff throughout the worldwide locations and external manufacturers to communicate, coordinate and track required documentation in support of post-approval CMC activities of the assigned drug products.

Keywords: Beacon Hill Staffing Group - Pharma, Philadelphia, CMC Technical Writer, Engineering, King Of Prussia, Pennsylvania

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