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Location: Lexington, MA (remote for the time being)
Duration: 6 Months (with a strong likelihood of extension into 2021)
An AP Bio client is looking for a submission specialist to assist with making documents submission ready, formatting, compiling into EDMS, bringing documents through QC/review process and other tasks related to various regulatory files. All candidates must have some familiarity/experience with eCTD, CMC, drug substance, drug product and regulatory submission documents as well as a scientific background. The ideal candidate is a quick learner who is comfortable using various tools like Microsoft Office Suite, Adobe PBS and ISR writer (not required to know, what must be able to learn quickly with provided training).
JOB ID# 226007