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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