This position is located in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Office of the Director (OD), Office of Clinical Research Support (OCRS). As a Regulatory Affairs Specialist, you will collaborate with the Office of Clinical Research Support, Program Officers and extramural offices, as well as serve as an expert advisor to leadership in order to establish and maintain regulatory best practices and implement project procedures.

Duties

As a Regulatory Affairs Specialist your duties will include but are not limited to the following: Serve as a sponsor for regulatory applications submitted to the Food & Drug Administration (FDA) for NIDDK extramural clinical trials as well as intramural studies conducted within the NIH/NIDDK clinical laboratories. Analyze, Develop and Standardize policies, procedures, and guidelines for Standard Operating Procedures (SOPs) for Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications, international drug regulatory policies, SAE identification and reporting. Serve as a the senior regulatory specialist and expert advisor to NIDDK leadership. Work with study teams to devise or advise on strategies to engage/collaborate with FDA on more challenging or higher risk protocols under IND/IDE. Monitor and provide guidance on regulatory activities. Manage IND and IDE activities and facilitate communications internally and externally. Ensure incoming and historical documents from FDA regulated studies are filed appropriately and the Investigator and Sponsor regulatory record is complete and in compliance with FDA regulations, guidance, policies and procedures. Establish standards for clinical site monitoring, essential regulatory document reviews and protocol activity tracking.

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.
• Position has an education requirement (please include transcripts).
• Financial Disclosure Form (OGE-450) is required.

Qualifications

In order to meet the Basic Qualification Requirements for a Regulatory Affairs Specialist, GS-0601-13, you must: Have a Bachelor's or higher-level degree from an accredited university with a major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of this position. AND In addition to the basic education requirements, you must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-12 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: providing expert regulatory guidance to investigators, team members, and pharmaceutical partners, including technical expertise, on the development of Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications and requests; preparing meeting requests and briefing documents and advising investigators on regulatory compliance; providing writing guidance for internal inspections; evaluating study documents and safety report cases for validity and consistency; and developing and maintaining liaison for site performance and compliance issues. 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/12414209

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: Joy Reding
• Email: [email protected]