ECTD publishing Manager, Regulatory Affairs

This role will support data mapping of eCTD metadata from our legacy publishing system into our future state system and support 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.

The eCTD 4.0 data mapping will be conducted first in our development environment before moving to production.

The ideal candidate will have experience with publishing system implementation and data mapping, Veeva Vault Publishing, Application Joins or Application Relationships including the XML field and mapping to eCTD.

Hybrid candidate preferred (3 days in office), open to remote.

• 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• Identifying out of date eCTD relationships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
• Corrections to the Veeva RIM archive as needed
• Mapping of current submission types and subtypes against Veeva and HA recommended nomenclature
• Mapping of existing submission records and fields into updated data models and fields
• Mapping eCTD 4.0 functionality in Veeva Publishing and executing end user testing as needed.

• Bachelor's degree, with a preference for life sciences or technology area

• Typically requires at least five to seven years hands‑on technical experience with eCTD publishing, either in Veeva Vault or similar publishing tools
• Experience with Veeva Vault RIM
• In depth hands‑on experience with eCTD publishing software, detailed understanding of eCTD metadata
• Proficient in Microsoft Office, especially Excel and formulas, e.g. Vlookup and pivot tables.
• Ability to organize and manage tasks with firm deadlines
• Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner

$60-$70/hr