- Prepared protocols for drug trials (Phases 1 through 3) and device trials.
- Produced investigator's brochures.
- Worked with interdisciplinary teams to produce Pre-IND Briefing Documents.
- Wrote previous human experience section and collaborated with project manager to coordinate submission of an IND.
- Worked closely with the regulatory department to write a Pre-NDA Briefing document in preparation for a client’s meeting with FDA.
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- Completed numerous integrated clinical/ statistical reports (Phases 1 through 3) for submission to FDA and other regulatory authorities.
- Collaborated with physicians from PAREXEL, an academic medical center, and/or the client’s regulatory department to write clinical expert reports for EC Dossiers.
- Collaborated with project manager to coordinate submission of an IND.
- Prepared summary documents for CTDs.
- Developed manuscripts for publication.
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