1. Select the statement below that best describes how you meet the basic requirement to qualify for the Consumer Safety Officer position:A. I have a bachelor's or higher degree that included at least 30 semester hours in one or a combination of the following: biological sciences, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical sciences, or a related scientific field that provided knowledge directly related to consumer safety officer work. The 30 semester hours can include up to 8 semester hours in statistics, course work that included the principles, theory, or practical application of computers or computer programming.
2. Select the statement below that best describes your specialized experience and/or education to minimally qualify for the GS-05 grade level:A. I have a bachelor's or higher degree that included at least 30 semester hours in one or a combination of the following: biological sciences, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical sciences, or a related scientific field that provided knowledge directly related to consumer safety officer work.
3. Select the statement below that best describes your specialized experience and/or education to minimally qualify for the GS-07 grade level:A. I have at least one full year of specialized experience that is equivalent in difficulty and complexity to work performed at the GS-05 level in the Federal service, that included assisting in reviewing drug submissions ensuring that all written reviews meet regulatory compliance; initiating administrative action to resolve discrepancies; preparing responses on the drug submission; coordinating the submission of drug reviews from initial receipt to completion ensuring time standards are met; and communicating with division staff and senior officials.
In this section, you are asked to evaluate yourself on task items using the scale provided. When making your ratings, please do not overstate or understate your level of experience and capability. You should be aware that your ratings are subject to evaluation and verification. Ensure that all claimed experience can be verified by the information in your resume. Do not give yourself credit for having performed tasks you have not performed. Deliberate attempts to falsify information will be grounds for not selecting you or for dismissing you from employment with the organization. For each task, select the ONE response that most accurately describes your current level of experience and capability.A- I have not had education, training or experience in performing this task.
4. Review a variety of IND/NDA/BLA submissions for regulatory compliance prior to final endorsement by Division Director.
5. Comprehend the organizational structures and interrelationships of compliance organizations and programs ensuring they relate to area of responsibility.
6. Review discipline inputs from internal and external entities ensuring that results conform to regulatory requirements.
7. Resolve all scientific and technical discrepancies prior to endorsement or disapproval.
8. Monitor drug submissions in assigned classes from initial receipt to completion.
9. Coordinate meeting requests from sponsors of drug to include circulation of meeting minutes.
10. Act upon the full range of violations within assigned drug area.
11. Evaluate test methods and new automated methods of processing and analyzing drug submissions.
12. Advise on new advances in technology related new programs, laws and regulations, significant court decisions and any new findings.
13. Initiate contact with industry officials to obtain basic incomplete or missing information on regulatory and scientific documents.
14. Develop and maintain effective communication with regulated industry, consumer groups and the general public.
15. Serve as point of contact concerning the application submission process.
16. Prepare memoranda, briefings and other background material concerning substantive issues, findings, and proposed solutions to keep management and appropriate staff involved at key decision points.
17. Prepare reports, papers and other written documentation that support investigative findings and recommendations.
18. Research and prepare response on drug submissions for the approval/disapproval of upper level management.Top of Form
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