Engineering: CMC Technical Writer - King Of Prussia, Pennsylvania - (King of Prussia, PA)

The CMC Technical Writer needs IV/Oral (tablets) Dosing product background and must have Module two and Module three Writing background 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. Collaborate 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. (01/12/2018)