Job Description

Position Overview:

  • The Technical Writer will sit within the Client Portfolio Strategy and Operations (PSO) Pipeline Portfolio Management Office (PMO).
  • This individual will be responsible for delivering CMC documentation (dossier and supporting documents) to support the regulatory strategy for the Cell Therapy clinical portfolio from early stage through registrational application.
  • This role requires effective collaboration across technical functions to deliver on timelines for submissions.
  • The position interfaces with experts in Process Development, Analytical Development, Cell Therapy Technical Ops, Quality and Regulatory Sciences across Client.
  • The successful consultant will work effectively in cross-functional project teams to accomplish company goals.


  • Responsibilities:
  • Co-authors / authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life cycle CM...
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