Technical Writer (Cell Therapy CMC)

  • Jersey City, NJ
  • Posted 4 hours ago | Updated 4 hours ago

Overview

On Site
Depends on Experience
Contract - W2
Contract - 12 Month(s)

Skills

technical writer
Cell Therapy
cmc

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.

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