Duties

Summary

The NIH is looking for Investigational New Drug Specialists who have experience in Investigational New Drug Applications (INDs) and Investigational Device Exemptions (IDEs) regulatory support and comprehensive knowledge of FDA regulations and the approval process of INDs and IDEs, so please make sure to highlight and thoroughly describe your experience in your resume.

Learn more about this agency

Responsibilities

• Serving as a liaison for clinical investigators and other clinical regulatory staff providing regulatory guidance, review, and expertise to ensure documentation conforms to applicable regulations and guidelines.
• Representing the NIH to regulatory bodies as the Sponsor's Authorized Representative for Investigational New Drugs and Investigational Device Exemptions applications.
• Leading the preparation of Investigational New Drug Applications to the FDA for initiating clinical trials ranging from Phase 1 to Phase 3.
• Ensuring incoming and historical documents from FDA regulated studies are filed appropriately and that the Investigator and Sponsor's regulatory record is complete and in compliance with FDA regulations, guidance, policies and procedures.
• Assisting investigators, boards, and Committees within the NIH IRP with the preparation for FDA inspections which includes providing the support, training, and follow-up for-cause and routine FDA Bioresearch Monitoring Program (BIMO) inspections.
• Writing guidance for NIH IRP Inspections.

Travel Required

Occasional travel - You may be expected to travel for this position.

Supervisory status
No

Promotion Potential
13

Requirements

Conditions of Employment

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• Position is subject to a background investigation.
• This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts.
• Position requires Education (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)
• Work Environment (The work is usually performed in an office setting, but may involve occasional exposure to conditions in facilities or hospital settings requiring safety precautions.)
• Applicants must meet all qualifications requirements within thirty (30) calendar days of the closing date of this announcement.
• Males born after December 31, 1959 must be registered with the Selective Service.
• At the supervisor's discretion, this position may offer work schedule flexibilities: telework.
• If selected, you must pass a pre-employment medical examination.
• This position is designated as a "non-emergency/teleworker" position.

Qualifications

Education Qualification Requirement for GS-12 and GS-13:
In order to qualify for a Investigational New Drug Specialist, GS-0601, 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).

Additional Qualification Requirement for GS-12:
In addition, in order to qualify for an Investigational New Drug Specialist, 601, at the GS-12 level, you must have at least one 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: maintaining historical documents from regulated studies to ensure they are filed appropriately; managing and evaluating Investigational New Drugs and Investigational Device Exemptions applications; assisting senior staff in revising standard operating procedures to adhere to applicable research regulations and guidelines; and preparing, submitting, and tracking safety reports for Investigational New Drugs and Investigational Device Exemptions projects.

Additional Qualification Requirement for GS-13:
In addition, in order to qualify for an Investigational New Drug Specialist, 601, at the GS-13 level, you must 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: developing new methods and procedures to resolve problems that affect the development of Investigational New Drugs and Investigational Device Exemptions; developing and implementing training programs to ensure senior leaders understand the requirements of serving as Investigational New Drugs and Investigational Device Exemptions sponsors; editing and submitting Investigational Device Exemptions applications that may include protocol amendments, supplements, annual reports, and safety reports; and designing and conducting comprehensive inspections and studies for regulated research.

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.

Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.

Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/10533300

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 .

Additional information

If you are unable to apply online or need to fax a document you do not have in electronic form, view the following link for information regarding an Alternate Application .

• This position is designated as a " non-emergency/teleworker " position and the selected candidate will be considered a " non-emergency/teleworker " employee. In the event of a closure, you must be available to telework or request leave.
• A one-year probationary period may be required upon selection/placement.
• The work is usually performed in an office setting, but may involve occasional exposure to conditions in facilities or hospital settings requiring safety precautions.
• If selected, you must pass a pre-employment medical examination.
• At the supervisor's discretion, this position may offer work schedule flexibilities: telework.
• PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should also apply online to this announcement in order to receive consideration.
• We may make additional selections for similar positions across the entire Department of Health and Human Services (HHS) within the local commuting area(s) identified in this vacancy announcement. By applying, you agree to have your application shared with any interested selecting official(s) at HHS. There is no option to opt-out as your information will not be shared with other hiring agencies outside of HHS.
• The National Institutes of Health participates in the USCIS Electronic Employment Eligibility Verification Program ( E-Verify ). E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers.
• The NIH maintains a tobacco free work environment and campus.

How You Will Be Evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

To determine your qualifications and referral status, a review of your resume and supporting documentation may be made and compared against your responses to the vacancy questionnaire. Because your rating is based on both your responses to the questionnaire and documentation you submit, please make sure that your self-ratings are supported by the information you provide in your application. Your qualifications and self-ratings may be verified at any time during the application and selection process through quality review, interview questions, work samples, demonstrations, reference checks, and any other means. Inflated or unsupported qualifications may affect your rating. Any misrepresentation or material omission of facts on the assessment questionnaire or in any other materials you submit in support of your candidacy (including but not limited to the application), or in any oral statements you may make during the selection process shall be sufficient cause to end further consideration of your candidacy. Persons listed as having knowledge of your past accomplishments or experience in your application may be contacted for verification purposes at any time. Verification may, but need not, begin prior to receiving an offer.

To be considered well qualified for the purposes of the Career Transition Assistance Program (CTAP) and the Interagency Career Transition Assistance Program (ICTAP), you must substantively exceed the basic qualifications by scoring at least an 85 on the assessment and meet all eligibility, physical, medical, suitability, and all other requirements.

Background checks and security clearance

Security clearance
Other

Drug test required
No

Position sensitivity and risk
Non-sensitive (NS)/Low Risk

Trust determination process
Credentialing , Suitability/Fitness

Required Documents

RESUME:

Your resume must thoroughly describe how your skills and experiences align to the criteria defined in the "Qualifications" section of this announcement and it must support your responses to the assessment questionnaire. We cannot assume you have performed the necessary experience required for this position regardless of your employment history or academic career. To ensure all of the essential information is in your resume, we encourage you to use the USAJOBS online Resume Builder . If you choose to use your own resume, you must ensure it contains all of the required information and you organize it so we can associate the following information for each experience/position:

Job title

Name of employer

Beginning and ending dates of employment (month/day/year format)

Hours worked per week. We will assume full-time unless otherwise stated. We will prorate part-time employment in crediting experience.

Detailed description of job duties, accomplishments, related skills, and responsibilities to include any supervisory/managerial responsibilities and number of staff supervised (if applicable)

Series and grade or equivalent (if a federal position)

If the position has an education requirement or you are qualifying on the basis of education, you need to list your education history including the type of degree and your major of study. If the position requires a certain number of credit hours, you are strongly encouraged to list the relevant courses in your resume.Do not include a photograph or video of yourself, or any sensitive information (age, date of birth, marital status, protected health information, religious affiliation, social security number, etc.) on your resume or cover letter. We will not access web pages linked on your resume or cover letter to determine your qualifications.

For resume writing guidance, please visit the following resources: NIH Jobs website , USAJOBS Resource Center , and the USAJOBS Resume Writing Video Tutorial .

Assessment Questionnaire:

You must submit a completed assessment questionnaire.

Eligibility Documentation:

To be considered eligible, you must submit the following documentation, if applicable to you AND respond accordingly to the associated question on the online questionnaire. If you do not provide the required information, we will assume you are not eligible or you do not wish to be considered for any preference or eligibility.

• - SF-50 - A copy of your most recent competitive career or career conditional SF-50 that shows the effective date of your latest position and the full performance level. You may obtain a copy of your SF-50 from your human resources office or, if you are an HHS employee, from your eOPF . If you separated from Federal Government employment, you may obtain a copy of your SF-50 via the Federal Records Center, National Archives and Records Administration .
• - Veteran Documentation for eligibility purposes only: (DD-214, VA Disability Letter, etc.). Reference Standard Form 15 (SF-15) for required documentation if you are a 10-point preference eligible. Submission of SF-15 is not required, unless you have derived preference (XP) as described in questions 7, 8, or 9 on the SF-15. In those cases, you must submit a completed SF-15 and the required documentation. For 5 point preference eligibles, you must submit your DD-214 (if separated) or any written documentation from the armed forces that certifies you are expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is submitted with your application package.
• - Schedule A (Disability Appointment) : Documentation of eligibility for employment under Schedule A can be obtained from a licensed medical professional (e.g., a physician or other medical professional certified by a state, the District of Columbia, or a U.S. territory to practice medicine); a licensed vocational rehabilitation specialist (i.e., state or private); or any Federal agency, state agency, or agency of the District of Columbia or a U.S. territory that issues or provides disability benefits. The letter must be printed on a medical professional's letterhead and signed. Please note the Schedule A hiring authority neither guarantees employment, nor gives an individual preference in the hiring process.
• - Documentation to support any other noncompetitive or OPM interchange agreement eligibility. Reference the Eligibility section of the questionnaire for required documents and information.
• - Visit our sites on Career Transition Assistance Program (CTAP) / Interagency Career Transition Assistance Program (ICTAP) for more information and required documentation .

Please do not submit any other supplementary documentation that is not requested of you. To protect your personal information, we will only send your resume and cover letter to the selecting official or hiring manager.

If you are relying on your education to meet qualification requirements:

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education .

Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.