Data Architect - MarkLogic

Documentation Analyst
Work Schedule: Mon - Fri, Business Hours
This Team is Remote

The Technical Writing and Document Management (TDM) function is responsible for delivering CMC documentation (Dossier and supporting documents) to support regulatory strategy for the Cell therapy portfolio from early stage through life cycle management.

The Document Specialist supports the documentation activities for regulatory submission content and supporting documentation for the cell therapy portfolio. This role requires effective collaboration across technical functions to deliver on timelines for submissions. The position interfaces with experts in Process Development, Manufacturing Sciences and Technology, Operations, Analytical Development, Quality, and Regulatory Sciences. The successful candidate will work effectively in cross-functional project teams to accomplish company goals.

1. Manage the logistical process and detailed timeline for CTD Quality sec...