Cell therapy CMC Technical Writer

JOB TITLE: Technical writer

Location: New Brunswick, NJ (50% Onsite)

Duration: 12 months initial (potential extension/potential right to hire)

Work Schedule: normal business hours

Travel: Occasionally to other local NJ sites for larger team meetings.(2-3 times a year)

Job Description

The Technical Writer and Document Specialist (TW/DS) will sit within the Cell Therapy Development (CTD) Project and Portfolio Management Office (PMO). This individual will be responsible for delivering CMC documentation (dossier and supporting documents) to support the regulatory strategy for a late-stage clinical cell therapy program.

This role requires effective collaboration across technical functions to deliver on timelines for submissions. The position interfaces with experts in Process Development, Analytical Development,...