Overview
Skills
Job Details
Role: Technical Writer (Cell Therapy CMC)
Location : Jersey City, NJ (Local to NY / NJ )
Contract
Must-Have Qualifications
Education: Bachelor s (or higher) in Biology, Biotechnology, or related scientific field.
Experience:
Minimum 2+ years in biotech/pharma technical or regulatory writing.
Cell Therapy CMC experience is mandatory.
Strong understanding of eCTD structure (Module 2.3 and 3); BLA submission experience highly preferred.
Technical Proficiency:
Skilled in Microsoft Office (Word, Excel, PowerPoint, SharePoint).
Experience with document management and publishing tools for regulatory submissions.
Soft Skills:
Excellent writing, editing, and attention to detail.
Strong project coordination, communication, and cross-functional collaboration abilities.
Able to work independently and meet tight deadlines.