Legal Instruments Examiner
This Direct-Hire position is in the Food and Drug Administration and is located in the Office of Regulatory Affairs (ORA). This position provides a variety of technical legal support and assistance to Compliance Officers and higher graded staff responsible for initiation, conduct, and completion of all actions (legal and administrative) taken by the Agency against violators of the Federal Food, Drug, and Cosmetic Act, as amended, and various related laws.
- Assists Compliance Officers in processing complex compliance actions.
- Examines and validates specialized legal documents such as applications, registrations, affidavits and others.
- Review inspection and analytical reports for recommendation of Untitled Letters.
- Reviews files to assure completeness and accuracy of necessary documentation, proper statutory charges and applicability of existing guidelines and policies.
- Provides status of transactions under consideration, reasons for exclusions, procedures involved in the approval process, and answers to other general questions.
- Prepares government and expert witnesses for trial. Participates in the interviews of potential witnesses, summarizing their prospective testimony, and suggesting questions for examination.
- Drafts correspondence and proposed letters for submission to appropriate SME for review and concurrence.
- Prepares reports, exhibits, and statistical analyses using office automation tools to be used in litigating cases.
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