Medical Writer II - (Alameda, CA)

Writes and edits various documents to support Clinical Development. Such documents may include clinical study reports (CSRs), common technical document (CTD) summaries for submission to regulatory agencies, protocols, Investigator Brochures, literature reviews, study manuals, and standard operating procedures (SOPs). Assembles CSR and CTD summary appendices and narratives. This is a full time, on-site position at our Alameda office. Job qualifications ESSENTIAL DUTIES AND RESPONSIBILITIES: Writes and edits CSRs, CTD summaries and other clinical trial documentation as necessary for submission to the Food and Drug Administration (FDA) or other regulatory agencies or for in-company use. Assembles CSR and CTD summary appendices and narratives. Edits, rewrites, or otherwise prepares drafts of Clinical Protocols and Investigator Brochures. Compiles, analyzes, and summarizes data from statistical tables and additional data from other sources as needed.