If you are an experienced Regulatory Affairs Specialist and you want to play a significant role in a dynamic organization, then consider joining the National Institutes of Health!
Summary
If you are an experienced Regulatory Affairs Specialist and you want to play a significant role in a dynamic organization, then consider joining the National Institutes of Health!
You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration. This job is also open to USPHS Commissioned Corps Officers and Call-To-Active Duty (CAD) Candidates.
Provide regulatory and protocol navigation support for assigned portfolio of clinical trials and Investigators.
Assist all aspects of the protocol lifecycle including scientific review, initial investigational new drug (IND) documents, institutional review board (IRB) submission of protocols, continuing review applications, protocol amendments, annual reports to other regulatory and safety bodies such as the Radiation Safety Committee (RSC) and the Institutional Biosafety Committee (IBC), and protocol inactivation
Prepare submissions for scientific review, institutional review board (IRB) review, investigational new drug (IND)/ Food and Drug Administration (FDA), safety monitoring committees/Data Safety Monitoring (DSMB), and other required committees.
Prepare and compile data from ongoing protocols and drafts annual continuing review reports for distribution to appropriate regulatory agencies.
Work with Investigators to ensure Data and Safety Monitoring Board (DSMB), Safety Monitoring Committee (SMC), or other safety reviews are completed in a timely manner.
Monitor key ethical and legal issues related to protection of research participants, adherence to policies and to Federal and state regulations surrounding the collection, storage, dissemination, and use of biospecimens and data.
Review documents for content, accuracy, and compliance with applicable regulations prior to submission to regulatory agencies.
Compile and maintain study essential regulatory document and files (digital and hardcopy) throughout the lifecycle of sponsorship.
Consult with research nurses, principal investigators, contractors, research sponsors, and regulatory personnel regarding regulatory issues and requirements and protocol adherence and interpretation.
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.
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.
Must be able to perform the essential duties of the position, with or without reasonable accommodation.
Based on your appointment, a one or two-year trial/probationary period may be required. A decision regarding your continued employment with NIH will be made as you near the end of this period.
Position requires Education. You are strongly encouraged to submit a copy of your transcripts (or a list of your courses included titles, credit hours completed, and grades.
Qualifications
Education Requirement: In order to qualify for a Regulatory Affairs Specialist GS-0601-13 position, 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).
In addition, to qualify for a Regulatory Affairs Specialist GS-0601 position at the GS-13 grade level, you must have: 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: (1) Leading protocol navigation activities, including coordinating scientific review, Institutional Review Board (IRB) and/or Investigational New Drug (IND) submissions, addressing stipulations, and facilitating clinical trial protocol development processes; (2) Managing a clinical trials portfolio by liaising with investigators/ study teams, regulatory agencies, and sponsors; tracking reviews of all review bodies; and maintaining accurate essential regulatory documentation; (3) Developing regulatory documents such as protocols, consents, and associated components in accordance with federal regulatory requirements; (4) Providing regulatory expertise by analyzing complex issues, preparing safety, annual, and/or progress reports, and recommending strategies to ensure compliance and expedite review processes.
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 or specialized experience from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position.
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.
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
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 newly appointed or reappointed employee may receive service credit for prior work experience or active-duty uniformed service that otherwise would not be creditable for the purpose of determining his or her annual leave accrual rate. All creditable service must be directly related to the duties of the position being filled and decisions to allow for such credit must be finalized prior to the selectee's entrance on duty. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations.
At the supervisor's discretion, this position may offer work schedule flexibilities: Alternative Work Schedules.
PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should apply online to this announcement to receive consideration.
Visit our Help Applying page for helpful information on the application process.
If you believe you have a disability (i.e., physical or mental), covered by the Rehabilitation Act of 1973 as amended that would interfere with completing the USA Hire Competency Based Assessments, you will be granted the opportunity to request a RA in your online application. Requests for RA for the USA Hire Competency Based Assessments and appropriate supporting documentation for RA must be received prior to starting the USA Hire Competency Based Assessments. Decisions on requests for RA are made on a case-by-case basis. If you meet the minimum qualifications of the position, after notification of the adjudication of your request, you will receive an email invitation to complete the USA Hire Competency Based Assessments, based on your adjudication decision. You must complete all assessments within 48 hours of receiving the URL to access the USA Hire Competency Based Assessments if you received the link after the close of the announcement. To determine if you need a RA, please review the Procedures for Requesting a Reasonable Accommodation for Online Assessments here: Reasonable Accommodation.
We may make additional selections for similar positions within the commuting area(s) of the locations listed through this vacancy announcement. By applying, you agree to have your application shared with any interested selecting official(s). Clearance of CTAP/ICTAP will be applied for similar positions.
Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution.
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
How you will be evaluated
You will be evaluated for this job based on how well you meet the qualifications above.
You will be evaluated based on how well you meet the qualifications listed in this vacancy announcement. Your qualifications will be evaluated based on your application materials (e.g., resume, supporting documents) and your responses to the assessments required for this position.
You will be assessed on the following competencies:
Attention to Detail
Customer Service
Flexibility
Integrity/Honesty
Interpersonal Skills
Reading Comprehension
Self-Management
Stress Tolerance
Teamwork
Overstating your qualifications and/or experience in your application materials or application questionnaire may result in your removal from consideration. Cheating on an assessment may also result in your removal from consideration.
The USA Hire Assessment includes a cut score based on the minimum level of required proficiency in these critical general competencies. You must meet or exceed the cut score to be considered. You will not be considered for the position if you score below the cut score or fail to complete the assessment.
If you meet the minimum qualifications for this position, your application and responses to the online questionnaire will be evaluated under Category Rating and selection procedures for placement in one of the following categories:
Best Qualified - for those who are superior in the evaluation criteria
Well Qualified - for those who excel in the evaluation criteria
Qualified - for those who meet the minimum qualification requirements
The Category Rating Process does not add veterans' preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Applicants determined to be Best Qualified will be referred for further consideration. Preference eligibles in the Best Qualified category are referred before all other applicants.
How You Will Be Evaluated
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 be able to satisfactorily perform the duties of the position upon entry and substantively exceed the basic qualifications by scoring at least an 80 on the assessment and meet all eligibility, physical, medical, suitability, and all other requirements.
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
RESUME:
Your resume must clearly demonstrate, in two pages or less, how your skills and experiences align with the "Qualifications" section and support your questionnaire responses. While cover letters provided with your application will be shared with hiring officials, they will not be used for initial qualification determinations. We cannot assume required experience based on your work or academic history. If your resume exceeds two pages, only the first two will be reviewed.
Use a legible font such as Lato, Calibri, Helvetica, or Arial, with 0.5-inch margins. Suggested formatting: 14-point for titles and 10-point for body text.
You may use the USAJOBS Resume Builder or upload your own resume. If uploading, ensure it includes all required information and is organized so we can match the following to each position:
Job title
Employer name
Employment dates (MM/DD/YYYY)
Hours worked per week (full-time assumed; part-time prorated)
Detailed duties, accomplishments, skills, responsibilities, and supervisory details (if applicable)
Series and grade or equivalent (for federal positions)
If the position has an education requirement or you are qualifying on the basis of education, you must 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 Help Applying, USAJOBS Resource Center, and the USAJOBS Resume Guidance. 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.
REQUIRED DOCUMENTATION FOR PREFERENCE OR ELIGIBILITY CLAIMS
To claim veterans' preference, career transition selection priority, Schedule A or military spouse eligibility, you must provide the documentation listed below AND respond accordingly to the associated question on the online questionnaire.
Veterans' preference (DD-214, VA Disability Letter, etc.): Reference Standard Form 15 (SF-15) for required documentation for 10 point claims. Submission of SF-15 is not required, unless you are claiming 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 claims, 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 Eligibility (Applicants with Disabilities) Applicants who are eligible to be considered under Schedule A must submit appropriate documentation to verify eligibility. Documentation must 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 on a medical professional's letterhead. Veterans' preference takes precedence in these appointments.
The Schedule A and military spouse hiring authorities do not guarantee employment or give an individual preference in the hiring process.
Do not submit 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(s).
If you are relying on your education to meet qualification requirements:
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.
Please read the entire announcement and all the instructions before you begin an application. To apply and be considered for this position, you must complete and submit all required questionnaires, assessments, and required documentation as specified in the How to Apply and Required Documents sections. The complete application package must be submitted by 11:59 PM (ET) on the closing date of the announcement to receive consideration. The application process is as follows:
Click Apply Online button.
Follow the prompts to select your resume and/or other supporting documents to be included with your application package. See the "Required Documents" section for any additional forms and/or supplemental materials required.
Read all Eligibility questions and respond accordingly to any Eligibility you wish to claim. You will only be considered for those Eligibility questions (Veteran, Schedule A, etc.) you respond in the affirmative to, regardless of what documentation you submit. We cannot assume you intended to respond differently to a question based on other information in your application package.
Complete the application questionnaire. Applicants are asked all questions regardless of their consideration preferences. We will only consider you for the grades, series, locations, specialties, and other considerations that you self-identify as being qualified for or interested in. Preview application questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12966441
After submitting an online application, you will be notified whether or not you are required to take additional online assessments through the USA Hire Competency Based Assessment system. This message will be delivered to you via email notification. The email may be routed to your "Spam" or "Junk" folder.
If you are required to complete any USA Hire Assessments, you will be notified after submitting your application. The notification will be provided in your application submission screen and via email. The notification will include your unique assessment access link to the USA Hire system and the completion deadline. Additionally, in USAJOBS you can click "Track this application" to return to your assessment completion notice.
Access USA Hire using your unique assessment link. Access is granted through your USAJOBS login credentials.
Review all instructions prior to beginning your assessments. You will have the opportunity to request a testing accommodation before beginning the assessments should you have a disability covered under the Rehabilitation Act of 1973 as amended.
Set aside about 2 hours to take the USA Hire assessments; however, most applicants complete the assessments in less time. If you need to stop the assessments and continue later, you can re-use your unique assessment link.
Your responses to the USA Hire Assessments will be reused for one year (in most cases) from the date you complete an assessment. If future applications you submit require completion of the same assessments, your responses will be automatically reused.
Verify all required documentation is included in your application package, review your responses to the application questionnaire for accuracy, and then submit your application.
In addition to the required documents, we encourage you to submit a cover letter, copy of your transcripts, and any applicable certifications or licenses. Even though this information is not required at the time of application, we may request this information later.
We cannot assume responsibility or grant extensions for personal issues (e.g., troubles navigating the application process, loss of internet, not understanding a question) when applying to our announcements. For technical difficulties, contact HR Systems Support between 8:00 AM and 4:30 PM ET Monday through Friday at hrss@nih.gov.
For reasonable accommodations not related to USA Hire, please contact Jamie Hammond at hammondje@mail.nih.gov. Requests for reasonable accommodations must be made before the announcement closing date.
Visit our site for information on NIH's EEO program, Reasonable accommodation procedures, laws, policy statements, and the operation of the EEO complaint process.
National Institutes of Health
6701 Rockledge Drive
Bethesda, MD 20892
US
Next steps
Based on your application and your responses to the application questionnaire, you may be presented with instructions on how to access the USA Hire system to complete the online assessments. The online assessments must be completed within 48 hours following the close of this announcement. You will have the opportunity to request a testing accommodation for the assessment should you have a disability covered under the Rehabilitation Act of 1973 as amended.
Once you submit your application package, you will receive an acknowledgment email with the status of your application. To track or update your application or supporting documentation, during the announcement open period, return to your USAJOBS account. This option will no longer be available once the announcement has closed. The Additional Application Information page provides information regarding the documentation you submitted and any correspondence we have sent related to this application, including the invitation to take the USA Hire assessment.
At the discretion of the agency, you may be contacted via phone or email for an interview or to provide additional information up to several months from the closing date of the announcement. Please ensure you have provided accurate contact information. To remain in consideration, you must respond in a timely manner to our correspondence and requests for documentation or information throughout the hiring process.
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
RESUME:
Your resume must clearly demonstrate, in two pages or less, how your skills and experiences align with the "Qualifications" section and support your questionnaire responses. While cover letters provided with your application will be shared with hiring officials, they will not be used for initial qualification determinations. We cannot assume required experience based on your work or academic history. If your resume exceeds two pages, only the first two will be reviewed.
Use a legible font such as Lato, Calibri, Helvetica, or Arial, with 0.5-inch margins. Suggested formatting: 14-point for titles and 10-point for body text.
You may use the USAJOBS Resume Builder or upload your own resume. If uploading, ensure it includes all required information and is organized so we can match the following to each position:
Job title
Employer name
Employment dates (MM/DD/YYYY)
Hours worked per week (full-time assumed; part-time prorated)
Detailed duties, accomplishments, skills, responsibilities, and supervisory details (if applicable)
Series and grade or equivalent (for federal positions)
If the position has an education requirement or you are qualifying on the basis of education, you must 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 Help Applying, USAJOBS Resource Center, and the USAJOBS Resume Guidance. 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.
REQUIRED DOCUMENTATION FOR PREFERENCE OR ELIGIBILITY CLAIMS
To claim veterans' preference, career transition selection priority, Schedule A or military spouse eligibility, you must provide the documentation listed below AND respond accordingly to the associated question on the online questionnaire.
Veterans' preference (DD-214, VA Disability Letter, etc.): Reference Standard Form 15 (SF-15) for required documentation for 10 point claims. Submission of SF-15 is not required, unless you are claiming 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 claims, 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 Eligibility (Applicants with Disabilities) Applicants who are eligible to be considered under Schedule A must submit appropriate documentation to verify eligibility. Documentation must 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 on a medical professional's letterhead. Veterans' preference takes precedence in these appointments.
The Schedule A and military spouse hiring authorities do not guarantee employment or give an individual preference in the hiring process.
Do not submit 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(s).
If you are relying on your education to meet qualification requirements:
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.
Please read the entire announcement and all the instructions before you begin an application. To apply and be considered for this position, you must complete and submit all required questionnaires, assessments, and required documentation as specified in the How to Apply and Required Documents sections. The complete application package must be submitted by 11:59 PM (ET) on the closing date of the announcement to receive consideration. The application process is as follows:
Click Apply Online button.
Follow the prompts to select your resume and/or other supporting documents to be included with your application package. See the "Required Documents" section for any additional forms and/or supplemental materials required.
Read all Eligibility questions and respond accordingly to any Eligibility you wish to claim. You will only be considered for those Eligibility questions (Veteran, Schedule A, etc.) you respond in the affirmative to, regardless of what documentation you submit. We cannot assume you intended to respond differently to a question based on other information in your application package.
Complete the application questionnaire. Applicants are asked all questions regardless of their consideration preferences. We will only consider you for the grades, series, locations, specialties, and other considerations that you self-identify as being qualified for or interested in. Preview application questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12966441
After submitting an online application, you will be notified whether or not you are required to take additional online assessments through the USA Hire Competency Based Assessment system. This message will be delivered to you via email notification. The email may be routed to your "Spam" or "Junk" folder.
If you are required to complete any USA Hire Assessments, you will be notified after submitting your application. The notification will be provided in your application submission screen and via email. The notification will include your unique assessment access link to the USA Hire system and the completion deadline. Additionally, in USAJOBS you can click "Track this application" to return to your assessment completion notice.
Access USA Hire using your unique assessment link. Access is granted through your USAJOBS login credentials.
Review all instructions prior to beginning your assessments. You will have the opportunity to request a testing accommodation before beginning the assessments should you have a disability covered under the Rehabilitation Act of 1973 as amended.
Set aside about 2 hours to take the USA Hire assessments; however, most applicants complete the assessments in less time. If you need to stop the assessments and continue later, you can re-use your unique assessment link.
Your responses to the USA Hire Assessments will be reused for one year (in most cases) from the date you complete an assessment. If future applications you submit require completion of the same assessments, your responses will be automatically reused.
Verify all required documentation is included in your application package, review your responses to the application questionnaire for accuracy, and then submit your application.
In addition to the required documents, we encourage you to submit a cover letter, copy of your transcripts, and any applicable certifications or licenses. Even though this information is not required at the time of application, we may request this information later.
We cannot assume responsibility or grant extensions for personal issues (e.g., troubles navigating the application process, loss of internet, not understanding a question) when applying to our announcements. For technical difficulties, contact HR Systems Support between 8:00 AM and 4:30 PM ET Monday through Friday at hrss@nih.gov.
For reasonable accommodations not related to USA Hire, please contact Jamie Hammond at hammondje@mail.nih.gov. Requests for reasonable accommodations must be made before the announcement closing date.
Visit our site for information on NIH's EEO program, Reasonable accommodation procedures, laws, policy statements, and the operation of the EEO complaint process.
National Institutes of Health
6701 Rockledge Drive
Bethesda, MD 20892
US
Next steps
Based on your application and your responses to the application questionnaire, you may be presented with instructions on how to access the USA Hire system to complete the online assessments. The online assessments must be completed within 48 hours following the close of this announcement. You will have the opportunity to request a testing accommodation for the assessment should you have a disability covered under the Rehabilitation Act of 1973 as amended.
Once you submit your application package, you will receive an acknowledgment email with the status of your application. To track or update your application or supporting documentation, during the announcement open period, return to your USAJOBS account. This option will no longer be available once the announcement has closed. The Additional Application Information page provides information regarding the documentation you submitted and any correspondence we have sent related to this application, including the invitation to take the USA Hire assessment.
At the discretion of the agency, you may be contacted via phone or email for an interview or to provide additional information up to several months from the closing date of the announcement. Please ensure you have provided accurate contact information. To remain in consideration, you must respond in a timely manner to our correspondence and requests for documentation or information throughout the hiring process.
Fair and transparent
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
