1. Select the statement below that describes how you meet the Basic Requirements for this position.A. I possess a degree in behavioral or social science; or related disciplines appropriate to the position. (Please provide transcript)
2. Select the statement that describes how you meet the Specialized Experience for this position at the GS-14 level.A. I have at least one year of specialized experience, equivalent to the GS-13 grade level or higher in the Federal service, providing technical guidance on over-the-counter drug labeling protocols; developing and conducting drug labeling studies, such as comprehension, self-selection, and actual-use studies; collaborating with various scientific staff in reviewing and analyzing data pertaining to drug labeling; and, developing and providing guidance on social science issues.
For each of the items below, select the one statement that most accurately describes your experience and capability using the scale below.A- I have no experience in performing this work behavior.
3. Participate in the development and design of language for prescription-to-over-the-counter switch product labels.
4. Assist a drug review team in ensuring drug labels contain relevant medical information in compliance with the Drug Facts Format.
5. Collaborate with statisticians and medical officers to evaluate study questions, ensuring they address relevant medical matters.
6. Develop studies to test the effectiveness of new communication tools.
7. Collaborate with medical officers or similar officials to review data on consumer use of over the counter drugs.
8. Review labeling language related to the tentative final and final over the counter drug monographs to ensure labels are complete, in regards to medical content and federal regulations.
9. Analyze data from label comprehension studies to determine the level of understanding of average and low literacy consumers on the tested labels.
10. Present data on label comprehension, self-selection and actual use studies at advisory committee meetings.
11. Lead staff in the writing of guidance on over-the-counter drug development processes.
12. Provide advice to industry representatives and/or government agencies on labeling information to over-the-counter (OTC) monographs, OTC new drug applications, and OTC drug products.
13. Participate in the creation of study designs to test the effectiveness of new communication tools aimed to assist consumers' understanding on the use of OTC drug products.
14. Write guidance in resolving social science issues as it pertains to an OTC drug development process.
15. Develop communication tools to assist consumers' understanding of how to use over the counter drug products.
16. Create package inserts for drugs aimed to ease consumer understanding.