This position is located in the Office of the Clinical Director (OCD), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). As Regulatory Affairs Specialist, you will be responsible for providing assistance, technical direction, and coordination of Repository interactions with NIDDK-funded study groups. Incumbent reviews external requests for access to Repository materials, and develops and monitors policies and guidance to adhere to NIDDK/NIH policies.

Duties

Provide advice and guidance related to repository practices and procedures. Provide technical direction to and participate in oversight of the performance of repository contractors. Manage data and biospecimens for statistical analyses and scientific review and collect and archive data and biosamples. Establish and manage tracking databases for regulatory activities for NIDDK sponsored clinical studies. Review and submit new protocols, protocol amendments, adverse event reports, annual reports, and study product information. Regularly function as part of a multi-disciplinary team to facilitate clinical studies and provide appropriate regulatory support and advice.

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 a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
• Applicants must meet all qualification requirements by the closing date of this announcement.
• Males born after December 31, 1959 must be registered with the Selective Service.
• Position has an education requirement. Please submit transcripts.

Qualifications

Basic Qualifications In order to qualify for a Regulatory Affairs Specialist, GS-0601, position you must have successfully completed 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 (https://ope.ed.gov/accreditation) at the time the degree was obtained). Additional Qualifications GS-12: In addition, to qualify for a Regulatory Affairs Specialist position at the GS-12 level, you must demonstrate at least one year of 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: providing regulatory guidance, review, and assistance to clinical investigators and other clinical regulatory staff; reviewing clinical protocols for regulatory compliance and internal consistency; ensuring Investigational New Drug (IND) and Investigational Device Exemption (IDE) products are in compliance with regulations and industry best practices; supporting maintenance of safety trackers and databases; and providing professional and technical assistance to staff and research study teams. 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. 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. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12130156

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 Dr Bethesda, MD 20892 US
• Name: Jeanira Johnson
• Email: [email protected]