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.

Education and Experience

Required:


Bachelor's degree or equivalent in relevant discipline with a minimum of 2 years' experience (4-7 years for senior level).
Familiarity with eCTD structure for regulatory submissions is required.
Outstanding verbal and writing communication skills, attention to detail, strong planning, organizational and negotiating skills, with focus on timely delivery.
Proficiency in commonly used applications like Word/Excel is required. Documentum experience is preferred.

Experience with regulatory documentum software is required along with proficiency in compliance ready standards for final publication is a strong asset.
Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines.
Possess strong interpersonal skills and demonstrate the ability to effectively interact with business functions.