This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/job/479080400. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.
Who May Apply: Federal employees with career or career-conditional appointments in the competitive service; former Federal employees with reinstatement eligibility based on previous career or career-conditional appointments; displaced Federal employees requesting special priority selection consideration under the Career Transition Assistance Plan (CTAP) and the Interagency Career Transition Assistance Program (ICTAP); veterans who are preference eligibles or who have been separated under honorable conditions after 3 years or more of continuous active service; Military Spouses; PHS Commissioned Corps Officers; individuals eligible for VRA appointments (at the GS-11 and below grade levels); and individuals with disabilities.
PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.
ALL APPLICANTS MUST SUBMIT AN SF-50, that verifies your eligibility for competitive placement (I.E. Federal status and time-in-grade), CTAP, or COMMISSIONED CORPS DOCUMENTATION.
This position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Center for Tobacco Products (CTP), Office Of Science (OS), located in Silver Spring, Maryland. The Office of Science (OS) will be permanently relocated to Beltsville, Maryland, tentatively scheduled for spring 2018.
This vacancy is also being announced concurrently with vacancy announcement FDA-CTP-17-DE-2007283SW under competitive procedures. Please review that announcement to see if you are eligible for consideration under competitive procedures. NOTE: Applicants must apply separately for each announcement in order to be considered.
Additional selections may be made within the same geographical area FDA-wide.
Learn more about this agency09/11/2017 to 09/22/2017
$94,796 - $123,234 per year
GS 13
2 vacancies in the following location:
Occasional travel - 2% Domestic annually
No
Permanent
Full-time - Full Time
13
No
FDA-CTP-17-MP-2009293SW
479080400
As a Regulatory Information Specialist
1. Provide direction and oversight of computerized regulatory information/data pertaining to products regulated by an office.
2. Review activities for quality assurance pertaining to the integrity and accuracy of regulatory information already in the system and new data entered.
3. Interact with data reviewers and managers to assure they place the correct interpretations on information contained in submissions when making determinations about data to be placed into a computerized regulatory system.
4. Validate information in the system for accuracy and completeness.
5. Analyze information available in existing systems and discuss reporting needs with data reviewers, supervisors, and managers.
6. Coordinate with senior level specialists in identifying the need to make modifications to current information or additions of new information.
Additional Conditions of Employment:
1. Security and Background
Requirements: Appointment will be subject to the applicant's successful
completion of a background security investigation and favorable
adjudication. Failure to successfully meet these requirements may be
grounds for appropriate personnel action. If hired, a background
security reinvestigation or supplemental investigation may be required
at a later time. Applicants are also advised that all information
concerning qualifications is subject to investigation. False
representation may be grounds for non-consideration, non-selection
and/or disciplinary action.
2. E-Verify: If you are selected for
this position, the documentation you present for purposes of completing
the Department of Homeland Security (DHS) Form I-9 will be verified
through the E-Verify System. Federal law requires DHS to use the
E-Verify System to verify employment eligibility of all new hires, and
as a condition of continued employment obligates the new hire to take
affirmative steps to resolve any discrepancies identified by the
system. The U.S. Department of Health and Human Services is an E-Verify
Participant.
3. Direct Deposit: All Federal employees are required
to have Federal salary payments made by direct deposit to a financial
institution of their choosing.
4. Pre-employment physical required: No
5. Drug testing required: No
6. License required: No
7. Mobility agreement required: No
8. Immunization required: No
9. A background investigation may be required.
10.
Incentives may be authorized; however, this is contingent upon funds
availability. If authorized, certain incentives will require you to sign
a service agreement to remain in the Federal government for a period of
up to 3 years. Note: This statement does not imply nor guarantee an
incentive will be offered and paid. Incentives include the following:
moving expenses, recruitment or relocation incentive; student loan
repayment, superior qualifications appointment, creditable service for
annual leave for prior non-federal work experience or prior uniformed
military service, etc.
11. Bargaining Unit Position: Yes
In order to qualify for the Regulatory Information Specialist, GS-301-13, you must meet the following minimum experience:
Have one year of experience equivalent to at least the GS-12, grade level in the Federal service, which includes analyzing regulatory information in databases for accuracy and completeness; and recommending modification of data to management.
In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.
You will be evaluated for this job based on how well you meet the qualifications above.
If after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible or your score may be adjusted to more accurately reflect your skills and abilities.
Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Merit Promotion Procedures for the Food and Drug Administration (FDA) procedures will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be ranked into one of two categories: Best Qualified or Qualified.
Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics):
1. Technical Competency
2. Data Analysis
3. Data Information Systems
4. Written Communication
5. Oral Communication
Applicants may also submit the following supporting document type(s),which may not be required for all applicants:
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.
Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We expect to make a selection within 45 days of the closing date of this announcement.
You will receive notice via email or by mail, if no email address was provided by you during the application process, once this process is completed (generally 4-6 weeks).
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/job/479080400. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.
Learn more about
Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.
The Center for Tobacco Products (CTP) of the Food and Drug Administration (FDA) is responsible for implementing the Family Smoking Prevention and Tobacco Control Act. This law gives FDA authority over tobacco products by adding a new chapter to the Food, Drug and Cosmetic Act. The Tobacco Control Act gives FDA the authority to regulate tobacco products and manufacturers based on the best available science and CTP is responsible for both assessing and fostering that science-base. CTP's actions have significant public health and consumer protection impact, and are among the most important issues faced by the Agency in its long and distinguished history.