Review technical documentation (protocols, reports) associated with manufacturing, tech transfer, site-to-site transfers and PPQ as needed * Conduct data review and analysis, data-driven decision-making process and support data transfer to the appropriate data repository - liaison between data digitalization team and the site * Support the compilation and technical review of relevant CMC sections of regulatory submissions (INDs/IMPDs, NDAs, MAAs, BLAs, etc.), responses to regulatory questions, briefing books
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