At least 1 year of experience publishing, compiling, QC, Validating electronic submissions IND, MAA, NDA CTAs; at least 1 year of experience using ISITRS Toolbox, eCTD publishing tools; at least 1 year of experience archivingfiling Regulatory submissions and correspondence in Veeva RIMS; at least 1 year of experience with any eTMF software and TMF regulatory zones

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