About the role
Duties
Implement program and projects to identify, assess, and prioritize the public health significance and patient risk associated with drug quality and safety concerns. Lead working groups of scientific, regulatory and legal experts within the Center and across the Agency to develop new or revised regulations and drafts the resulting notices of proposed rulemaking. Prepare reports and/or written analyses regarding FDA policies and positions on difficult complex matters.
Qualifications
In order to qualify for Senior Regulatory Counsel, GS-0301-15, you must meet the following: Have one year of specialized experience, equivalent to the GS-0301-14 in the Federal service, analyzing and evaluating highly complex drug law related to drug development and approval, compliance and/or citizen petitions and guidance; providing authoritative advice on complex regulatory statues, including the Federal Food, Drug and Cosmetic Act (FDCA) and Public Health Service Act and working to develop complex policies as they pertain to the pharmaceutical industry. Documenting experience: In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.
Education
If you are claiming education as any part of your qualifications for this position, you must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program. For further information, click on foreign education.
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