Regulatory Affairs Specialist
Company
Department of Health and Human Services - National Institutes of Health
Location
Montgomery County, Maryland Montgomery County, Maryland
Type
Full Time
Job Description
Summary
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.
Learn more about this agencyRequirements
Conditions of Employment
- 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 include transcripts).
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.
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/12410037
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
- This position is designated as a Tier II "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.
- At the supervisor's discretion, this position may offer work schedule flexibilities: [telework (work from home on a regular basis or ad hoc basis but reports to the office at least once a week/two days a pay period), compressed 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
- 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.
- 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.
- Visit our Applicant FAQs page for helpful information on the application process.
- Visit our Total Compensation page and this sample for a detailed look into the benefits, awards, leave, retirement, and other incentives employees may receive as part of a rewarding work environment.
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Date Posted
06/07/2024
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