Danielle Pierre
Director, Medical Writing Services @精鼎医药
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WORK HISTORY
Director, Medical Writing Services @精鼎医药
Decentralized from Toronto, ON, CA
EDUCATION
University of Toronto
Honours Bachelor of Science, Human Biology, Bioethics
ABOUT DANIELLE PIERRE
Leads cross-functional teams through regulatory document development. Finds inefficiencies and streamlines processes. Drives SOP and template improvements. Reviews budgets and prepares invoices.Experienced in a variety of early- and late-phase research including safety, efficacy, therapeutic/exploratory, PK, bioequivalence, dose-escalation, and food-effect studies. Wrote a dozen templates and over 700 regulatory and supporting documents including clinical study reports (CSR), protocols and amendments, informed consent forms (ICF), investigator\'s brochures (IB), package inserts (PI), briefing books, and responses to regulatory queries.Created documents and systems to support departments including SOPs, style guidelines, and project management databases.
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