This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/job/478316500. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.
This announcement covers multiple positions with the Department of Health of Human Services (DHHS), Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), including the following CDER offices:
The Office of New Drugs (OND) provides regulatory oversight for investigational studies during drug development, makes decisions regarding marketing approval for new drugs, including decisions related to changes to already marketed products, and provides guidance to regulated industry on a wide variety of clinical, scientific and regulatory matters.
The Office of Translational Sciences (OTS) promotes innovation in drug regulatory review across CDER. OTS assures the validity of clinical trial design and analysis by developing and applying quantitative and statistical approaches in the regulatory review process.
The Office of Medical Policy Initiatives (OMPI) provides oversight and direction for new and ongoing policy initiatives in broad-based medical and clinical policy areas, including initiatives to improve the science and efficiency of clinical trials, promote clinical trial quality, and enhance patient labeling.
The Office of Pharmaceutical Quality (OPQ) provides oversight of product quality throughout the lifecycle of a drug product and assures that quality medicines are available to the American public.
The Office of Surveillance and Epidemiology (OSE) is responsible for monitoring the safety of drugs and therapeutic biologics used by the American people.
The Office of Generic Drugs (OGD) is responsible for the oversight and review of generic drug products. OGD is the leader in the science and regulation of generic medicines, enabling innovation in generic drug development, evaluation, and surveillance.
This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-17-MP-200615JW under merit promotion procedures. Please review that announcement to see if you are eligible for consideration under merit promotion procedures.
NOTE: Applicants must apply separately for each announcement in order to be considered.
Who May Apply: Open to all United States Citizens.
Additional selections may be made within the same geographical area FDA-wide.
Learn more about this agency09/05/2017 to 12/31/2017
$79,720 - $123,234 per year
GS 12 - 13
Not required
No
Permanent
Full-time - Full Time
13
No
FDA-CDER-17-DE-2006016JW
478316500
As a Regulatory Health Project Coordinator/Manager, GS-601-12/13, you will perform the following duties:
Conditions of Employment:
In order to qualify for Regulatory Health Project Coordinator/Manager, GS-0601-12/13, you must meet the following:
BASIC QUALIFICATIONS:
Degree: major study in an academic field related to the health sciences or allied sciences appropriate to the work of the position.
AND
In addition to the basic qualification requirement described above, the following additional experience are required. Your application or resume must clearly show that you possess the specialized experience requirements.
GS-12: Have one year of specialized experience, equivalent to the GS-11 in the Federal service, which includes serving as a project manager reviewing and evaluating regulatory requirements for the drug application process.
GS-13: Have one year of specialized experience, equivalent to the GS-12 in the Federal service, which includes coordinating or leading scientific projects in collaboration with regulatory staff and multidisciplinary, matrix designed teams, to include clinicians, chemists, biologists, toxicologists, pharmacologists, and/or statisticians, in the drug review process; and ensuring legal, regulatory and policy requirements/compliance associated with drug development.
If you are claiming education as any part of your qualifications for this position, you must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program. For further information, click on foreign education.
If you are serving, or have served in the last 5 years (from the close of this announcement) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment.
Males born after December 31, 1959 must be registered or exempt from Selective Service (see http://www.sss.gov).
For information on employment for People with Disabilities please visit http://opm.gov/disability/PeopleWithDisabilities.asp
Career Transition Program: This program applies to Federal workers whose positions have been deemed "surplus" or no longer needed, or an employee who has been involuntarily separated from a Federal service position within the competitive service. To receive selection priority for this position, you must be rated "well-qualified". Well-qualified means eligible applicants whose knowledge, skills, and abilities clearly exceed the minimum qualification requirements of the position. For information on how to apply and what documents to submit as an ICTAP eligible, see: http://www.opm.gov/rif/employee_guides/career_transition.asp
You will be evaluated for this job based on how well you meet the qualifications above.
Once the job opportunity announcement closes, a review of your résumé and supporting documentation will be made and compared against your responses to the assessment questionnaire to determine if you are qualified for this job.
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.
Basis of Rating: Category rating 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 assigned to one of the following quality categories: Best Qualified, Well Qualified or Qualified.
The Category Rating Process does not add veteran's preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 10 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).
Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You do not have to respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of the Competencies/KSA's.
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. Once this process is completed, you will be notified of your status via e-mail.
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/478316500. 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.
This is an Open Continuous Announcement with a closing date of December 31, 2017. The initial cut-off date for referral is September 19, 2017. After this date, additional referral lists will be created every 4 weeks as vacancies are available.