The Research Regulatory Affairs-Facilities organization within ORSC provides regulatory support for the various cGMP and compounding facilities on campus. Support includes guidance in meeting the regulatory requirements with regards to facility design and facility operations. The area maintains centralized resource contracts such as for specialized cleaning and preventative maintenance, will aid in FDA Inspections of facilities, aide in development of Quality Systems, and responses to audits.

Duties

As a GS-0601 Regulatory Affairs Specialist in the Clinical Center, your duties may include but are not limited to the following: Direct responsibility using knowledge of regulatory statutes and guidance for the oversight and monitoring of NIH research facilities to ensure compliance with pertinent regulations, applicable policies, standards and procedures as well as with state of the art methods using sound scientific principles as they apply to regulated cleaning services, pest management, regulatory required environmental monitoring, qualification and management of manufacturing materials and hospital supplies. Use regulatory knowledge of the requirements for cGMP and compounding facilities; selects, qualifies and oversees the speciality contracts for cleaning services, pest management, environmental monitoring (to include indentification of specific disinfectants based on the microbial results from monitoring), materials management and vendor qualifications for suppliers. Provide high level consultative support to the Clinical Center and Institute departments including Pharmacy/IVAU Department, Department of Transfusion Medicine (DTM), Department of Laboratory Medicine (DLM), Positron Emission Tomography (PET) Department, and the Nuclear Medicine Department, NCI Surgery Branch and NIAID Malaria Branch regarding regulatory compliance with the U.S. Food and Drug Administration (FDA) regulations, USP and other pertinent regulations and policies and industry standards regarding research facilities. Provide regulatory support for investigators from NIH Institutes performing FDA regulated research including assisting investigators in meeting the Food and Drug Administration requirements and in reviewing and preparing protocols. Use expertise in FDA and USP regulations and guidance, identifies and designs customized audit and evaluation surveys for each facility, develops protocols to evaluate and validate internal and external research facilities to ensure they meet the regulatory statutes and NIH manufacturing and compounding quality requirements. Prepare NIH guidance and policy; identifies core manufacturing staff technical competencies and provides training; and determines opportunities for efficiencies, effectiveness and cost savings in research facilities throughout the NIH. Develop appropriate metrics regarding the quality of research facilities and monitors and reports on them.

Requirements

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• Employment is subject to the successful completion of the pre-appointment process (i.e., background investigation, verification of qualifications and job requirements, completion of onboarding forms, submission of required documents, etc.)
• Males born after December 31, 1959 must be registered with the Selective Service.
• Applicants must meet all qualifications requirements within thirty (30) calendar days of the closing date of this announcement, including time in grade.
• This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts.
• If selected, you must pass a pre-employment medical examination, provide evidence of immunization, and be free from communicable diseases.
• At the supervisors discretion, this position may offer work schedule flexibilities: Telework and Alternative Work Schedules.
• This position is designated as an "emergency essential" position. See definition of this designation in the Additional Information Section of this announcement.

Qualifications

Basic Education Requirement for GS-601: In order to qualify for a Regulatory Affairs Specialist-GS-601, position you must have successfully completed a full 4 year course of study in an accredited college or university leading to a Bachelor's degree or graduate/higher level degree with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. (This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained). In addition, in order to qualify for a Regulatory Affairs Specialist, 0601 at the GS-11 level, you must meet one (1) of the following qualification requirements: A. 3 years of progressively higher level graduate education leading to a Ph.D. degree or Ph.D. or equivalent doctoral degree; OR B. Have 1 year of specialized experience equivalent to at least the GS-9 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: assisting clinical investigators in meeting FDA regulatory research requirements; analyzing and revising protocols by ensuring regulations, guidelines, and practices of research facilities are followed; assisting in conducting evaluations and audits to evaluate and validate research facility operations; drafting and reviewingreports of findings to implement improvements and corrective action plans to ensure the compliance of regulations governing cGMP and compounding facilities; and arranging highly technical contracts for research facilities. OR C. have a combination of graduate education related to the position and experience that meets 100% of the qualification requirements for this position. In addition, in order to qualify for a Regulatory Affairs Specialist-GS-601, at the GS-12 level, you must meet the following requirement: Have at least one (1) year of qualifying specialized experience equivalent to at least the GS-11 level in the Federal Government obtained in either the private or public sector performing the following types of tasks: Interpreting and applying knowledge of various regulations, policies and procedures in research facilities; designing and conducting audits and surveys for the compliance of FDA and USP regulations; serving as a liaison and providing regulatory guidance for clinical investigators and other clinical regulatory staff; preparing a variety of materials including briefings, project papers, correspondence and presentations for leadership regarding the quality of research facilities;and preparing reports of audit findings and recommendations to improve research facility operations. Do not copy and paste the duties, specialized experience, or occupational assessment questionnaire from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position. You will receive credit for all experience material to the position, including experience gained in religious, civic, welfare, service, and organizational activities, regardless of whether you received pay. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12421876

Education

This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades). Unofficial transcripts will be accepted in the application package. Official transcripts will be required from all selectees prior to receiving an official offer. Click here for information on Foreign Education.

Contacts

• Address National Institutes of Health 6701 Rockledge Drive Bethesda, MD 20892 US
• Name: NIH HR Service Desk Branch E
• Email: [email protected]