This position is located in the Regulatory Affairs Branch (RAB), Office of Policy, Clinical, and Research Operations (OPCRO), Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS).

Duties

Collaboration with DAIDS program staff, facilitates the development of regulatory strategies, assembles and submits IND applications and/or TMFs to FDA, and maintains high quality IND applications and/or TMFs. Responsible for the oversight of paper and/or electronic TMFs within DAIDS, including implementation prior to study start, upkeep throughout the duration of the study, and proper archival for the Sponsor to meet regulatory requirements. Develop, maintain, enhance, and modify DAIDS policies and standard operating procedures on TMF and/or IND matters. Analyze and interpret regulations, policies, and procedures, and provides oral and written explanations and advice. Coordinate and communicate with other DAIDS, NIAID, and NIH components to ensure consistency and harmonization of TMF and/or IND procedures, strategies, and best practices. Serve as liaison with the OPCRO Protection of Participants, Evaluation and Policy Branch during Protocol Registration Office (PRO) team interactions. Provide guidance and training on TMF and/or IND regulations and procedures to DAIDS researchers and to domestic and international research organizations involved in DAIDS-sponsored clinical trials.

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 requires Education (You are strongly encouraged to submit a copy of your transcripts),

Qualifications

You qualify for a Health Scientist at the GS-13 level, if you meet the following qualification requirements: Education Requirement: You must possess 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 this 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). AND Additional Experience: Have at least one year of qualifying specialized experience equivalent to at least the GS-12 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks: coordinating the use and implementation of regulations, policies, procedures, and precedents regarding Investigational New Drugs (IND) and Trial Master Files (TMF) applications for biomedical research; analyzing IND and TMF policies and practices for a health science organization; providing advice and guidance to scientists or researchers on IND and TMF policy issues; and coordinating or providing IND and TMF training to staff or stakeholders. 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. To determine your qualifications and referral status, we may review your resume and supporting documentation and compare it against your responses to the vacancy questionnaire. Ensure you support your self-ratings with the information you provide in your application. We may verify or assess your qualifications at any time. Inflated or unsupported qualifications may affect your rating. Any misrepresentation or material omission of facts may be sufficient cause to end further consideration of your candidacy. Persons listed as knowing your past accomplishments or experience in your application may be contacted for verification purposes at any time. Verification may, but need not, begin before receiving an offer. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12424670

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: Susie Yi-Miller
• Phone: 301-761-7051
• Email: [email protected]