Vivian M. Hernández
- Role
- Manager, Regulatory Writing at Amgen
- Location
- Cambridge, MA, US
- LinkedIn followers
- 500 followers
About Vivian M. Hernández
Experienced nonclinical medical writer with a demonstrated history of working in the…
Experience
Manager, Regulatory Writing
Jan 2021 — Present
Generate and support generation of regulatory strategy, clinical, nonclinical, and analytical content for a variety of regulatory submissions (eg, briefing books, IND, MAA) in Amgen\'s biosimilars portfolio -Work on cross-functional teams to coordinate generation, reviews, and approvals of documents and facilitate communication between product leads, regulatory leads, and subject matter experts
Skills
- Science
- Microscopy
- Statistics
- Data Analysis
- Cell Culture
- Neuroscience
- Cell Biology
- Slice Electrophysiology
- Matlab
- Clinical Research
- Research
- Molecular Biology
- Bioengineering
- Confocal Microscopy
- Pcr
- Scientific Writing
- Molecular Cloning
- Immunohistochemistry
- Fluorescence Microscopy
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