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As a Social Science Analyst in the Division of Nonprescription Clinical Evaluation, Center for Drug Evaluation and Research (CDER), you will be responsible for evaluating 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-MP-13-927546 under merit promotion procedures. Please review that announcement to see if you are eligible for consideration under merit promotion procedures. NOTE: Applicants must apply separately for each announcement in order to be considered.
This job opportunity announcement may be used to fill additional vacancies.
Collaborates with regulatory and scientific staff to ensure Drug Facts labeling is consistent with regulations.
- 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.