Sydney M. Gibson
Regulatory Strategy | ex-FDA | Real World Evidence
- Role
- Associate Principal, Real-world Regulatory Science & Strategy at IQVIA
- Location
- Washington, DC, US
- LinkedIn followers
- 500 followers
Experience
Associate Principal, Real-world Regulatory Science & Strategy
Jan 2023 — Present · Washington, DC, US
Regulatory strategist for leveraging real-world evidence for drugs and medical devices, including AI-enabled software, SaMDs, orphan products, and tissue engineered products- Leads consultative support in the design and execution of innovative studies that leverage real-world data and evidence (RWD/RWE) for regulatory decision-making- Conducts competitive regulatory strategy and evidence landscaping activities for drugs, devices, and combination products for US and Ex-US regulatory decisions.
Education
University of Pittsburgh
Bachelor of Science (B.S.)
Rice University
Doctor of Philosophy (Ph.D.)
Skills
- Optical Microscopy
- Biomedical Engineering
- Team Leadership
- Biotechnology
- Minitab
- Technical Writing
- Elisa
- Assay Development
- Research
- Matlab
- Statistics
- Photoshop
- Luminex
- Confocal Microscopy
- Bioengineering
- Tissue Engineering
- Product Development
- Public Speaking
- Cell Biology
- Cell Culture
- Laboratory
- Biomaterials
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