Clinical Analyst

Determines whether clinical trials of new drugs in humans are soundly conceived and supported by prior animal testing, and other controls adequate to justify tests in humans. Evaluates submissions from applicants seeking permission to market new drugs for general use and makes recommendations on the adequacy of the efficacy and/or safety data provided. Conducts labeling review and determines whether proposed labeling contains truthful claims for safety and effectiveness; and adequate directions for use and warnings against misuse. Makes recommendations on the accuracy of clinically relevant product information in the labeling and compliance with content requirements and all labeling regulations. Reviews periodic and annual reports submitted by applicants on drugs approved for marketing. Provides recommendations on clinical and safety data tables. Incorporates the summaries of pharmacologists and chemists as part of the decision-making process in determining whether to approve an applic