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U.S. Department of Health and Human Services

About FDA

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Description of Duties
  • Receives complaints or concerns regarding regulatory matters pending in ORA. Initiates investigations and other efforts directed to promote understanding and to attempt to resolve the disagreements and on other matters that are not the subject of a specific external complaint.
  • Performs a variety of substantive activities, such as: receiving and investigating complaints, disagreements and disputes; providing general information and interpretation of applicable Agency and ORA policies, process and procedures; exercising diplomacy, reason and persuasion to establish a conciliatory atmosphere conducive to mediation; conducting information gathering, data collection and fact finding across organizational lines and with affected persons and groups both inside and outside FDA; analyzing, appraising and evaluating information, data and facts and developing case histories and reports identifying significant problems and issues; and collaborating with parties concerning actions and approaches to achieve equitable and reasonable solutions that are mutually agreeable whenever possible.
  • Collaborates with the ACRA and other key ORA and FDA staff in reviewing policies and procedures, strengthening the various processes and making them more efficient, transparent, effective and fair.
  • Provides authoritative advice, guidance, assistance, interpretation and recommendations to the ACRA, senior executives; scientific, legal, and professional personnel; external stakeholders including industry officials and their representatives, and others in matters related to complaints and dispute resolution, including appeals of ORA decisions and actions. Develops, prepares, and presents authoritative memoranda, briefings, position papers and other materials concerning substantive questions, issues, findings, conclusions and proposed solutions or suggested courses of action.
  • Oversees dispute resolution and appeals processes that involve ORA.
  • Serves as a neutral and independent third party primarily for external stakeholders and, in the course of analyzing situations and recommending appropriate courses of action to resolve the issues, may provide one or several of the following services: listening impartially and questioning external stakeholders who contact the Ombudsman in order to help put the problem into perspective; providing information; reframing issues and developing options; referring the stakeholder to appropriate resources; ensuring that the stakeholders understand their options and the processes involved; and/or serving as a facilitator and engaging in shuttle diplomacy and informally looking into the problems.
  • Participates in ensuring complaints or concerns from foreign, federal, state, local, tribal, and territorial counterparts who consult for and partner with ORA to further the agency’s mission are handled in a timely and professional manner. Serves as an avenue for hearing and resolving disputes and concerns that may occur regarding their agreements and partnerships.
  • Develops annual reports providing frequency, source, subject matter, and disposition of complaints, disputes, and inquiries that the Ombudsman handled.
  • Makes presentations at meetings, conferences, and workshops to external and internal stakeholders on the role of the Ombudsman, what and how the incumbent may be of assistance to them.
  • Conducts and facilitates selected after-action reviews of ORA actions and decisions to develop lessons learned that could be applied to future similar situations.
Basic requirements for all grades in this position include:
  1. 4 academic years above high school leading to a bachelor’s degree, or Bachelor’s degree, OR
  2. One year of specialized experience, equivalent to the next lower grade level in the Federal service applying established methods and techniques to evaluate the efficiency or effectiveness of programs, work operations, or procedures; identifying trends or deficiencies with administrative or program operations and procedures; utilizing established databases to track time-sensitive documents; and reviewing scientific or technical documents for accuracy and completeness.  -OR-  B. A Master's or equivalent graduate degree; or 2 years of progressively higher level graduate education leading to such a degree in public administration, business administration, or a closely related field which provided the knowledge, skills, and abilities to do the work of this position.  -OR-  C. A combination of specialized experience as described in A and graduate education as described in B that, when combined, equal 100% of the total requirement. (Please note that only graduate education in excess of the first 18 semester hours may be used in this calculation.)
Grade (Salary) Level
This is aGS-15 opening at ORA Headquarters.
Geographical Locations
This position is located at ORA HQ (Rockville, MD).