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As a Social Science Analyst in the Division of Nonprescription Clinical Evaluation, Office of Drug Evaluation IV, you will evaluate a variety of complex label comprehension studies, self-selection studies, and actual use protocols to determine if they are well designed and adhere to over-the-counter (OTC) regulations.
This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-CDER-DE-13-927543 open to all U.S. Citizens. Please review that announcement to see if you are eligible for consideration under competitive procedures. NOTE: Applicants must apply separately for each announcement in order to be considered.
PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement under noncompetitive merit promotion procedures. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.
This job opportunity announcement may be used to fill additional vacancies.
- Reviews and performs in-depth analysis of label comprehension, self-selection, and actual use protocols.
- Analyzes labeling language related to the tentative final and final over the counter (OTC) drug monographs.
- Provides advice and recommendations on comprehensive language to use for prescription-to-OTC products.
- Leads the writing of guidance to address social science issues that pertain to OTC drug development process.
- Collaborates with regulatory and scientific staff to ensure Drug Facts labeling is consistent with regulations.