eCTD publishing Senior Specialist, Regulatory Affairs (Contract)

This role supports data mapping of eCTD metadata from our legacy publishing system into our future state system and supporting activities in preparation of enabling eCTD 4.0 submissions. The project work will mostly be conducted in Excel, working against data extracts from Veeva Vault RIM and requires a deep understanding of eCTD structure, metadata and organization as well as experience with Veeva Vault RIM. Person in this role will own portions of the data migration mapping to enable Veeva Publishing as well as preparation activities for eCTD 4.0 enablement, including, but not limited to: Mapping legacy eCTD metadata into Veeva RIM relationships, Identifying out of date eCTD relationships, Suggesting updates to align with historical dossiers and enable future lifecycle management. They will be mapping eCTD 4.0 functionality in Veeva Publishing and executing end user testing as needed.