This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/job/480526100. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.
This position is located in the Center for Biologics Evaluation and Research (CBER), Office of Tissue and Advanced Therapies (OTAT), Division of Regulatory Project Management (DRPM) located in Silver Spring, MD.
This vacancy is also being announced concurrently with vacancy announcement FDA-CBER-17-MP-2015007-LT 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 agency10/03/2017 to 10/17/2017
$79,720 - $123,234 per year
GS 12 - 13
Not required
No
Permanent
Full-time - Full Time
13
No
FDA-CBER-17-DE-2015001-LT
480526100
The incumbent of this position will:
· Provide guidance and consultation regarding methods and procedures necessary to accomplish primary review and project Management on license applicants (BLA's NDAs) investigational new drug submission (INDs), device submission and formal meetings.
· Review special and unusual problems and provide guidance to resolve the issues. Such issues deal with interpretations of law, policy and procedures.
· Provide support to agency to establish new or receiving regulations, procedures and program with national and international impact.
· Draft response to correspondence from within and outside the agency concerning regulated products.
Additional Conditions of Employment:
BASIC EDUCATION REQUIREMENT:
All applicants must meet the following education requirement:
Degree: A bachelor's or graduate/higher level degree in quality assurance or a related degree that included at least 30 semester hours in one or a combination of the following: consumer laws, biological sciences, food science, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, legal investigations, law enforcement, or related scientific fields that provided knowledge directly related to consumer safety officer work.
The 30 semester hours may include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming.
OR
Combination of education and experience--courses consisting of at least 30 semester hours in the fields of study described in paragraph A above, plus appropriate experience or additional education.
SPECIALIZED EXPERIENCE REQUIREMENT:
IN ADDITION TO MEETING THE BASIC EDUCATION REQUIREMENT, ALL APPLICANTS MUST ALSO:
In order to qualify for the position of CONSUMER SAFETY OFFICER, GS-0696-12, you must have one year of specialized experience, equivalent to the GS-11 in the Federal service examples of specialized experience planning and organizing the work of review teams to accomplish a variety of concurred activities performed in the office.
In order to qualify for the position of CONSUMER SAFETY OFFICER, GS-0696-13, you must have one year of specialized experience, equivalent to the GS- 12 in the Federal service examples of specialized experience planning and organizing the work of review teams to accomplish a variety of concurred activities performed in several organizations in support of the product approval process; maintain constructive working relationships among all parties, to achieve appropriate and timely support, and to reconcile divergent viewpoints.
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.
1. Ability to recognize the need for and develop new procedures to solve critical or novel problems
2. Ability to advise others in the application of Agency rules, regulations and procedures
3. Skill to identify problems, gathering information, drawing conclusions, recommending solutions,.
4. Ability to communicate orally.
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/480526100. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.
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