Project Manager (Associate Manager, Regulatory Project Management)
July 2016 — Present
• Manage regulatory submissions (e.g., INDs, PIPs, sNDAs) during drug development and postmarketing stages for US, EU, Japan from kickoff to e-submission; build timelines using MS Project & Visio; facilitate filing strategy and logistics meetings; find solutions to mitigate risk, and proactively build strong lines of communication between functions.
• Coordinate with leads from nonclinicial (pharmacology, DMPK, toxicology), clinical research, portfolio PM, biometrics, medical writing, drug safety and public health, clinical pharmacology, clinical operations, clinical virology, publishing/doc processing, in partnership with Global Regulatory Leads (GRLs).
• Generate internal process improvement methodologies, guidance documents, etc to reduce repetitive work and inefficiencies.
• Women at Gilead Employee Resource Group Events Co-lead.