Department:Department Of Health And Human Services
Agency:Food and Drug Administration
Job Announcement Number:HHS-FDA-MP-13-936530
This position is closed and no longer accepting online applications through USAJOBS.
The contents of the announcement can still be viewed.
/ Per Year|
|Wednesday, August 07, 2013 to
Tuesday, August 20, 2013|
SERIES & GRADE:
|Full Time -
|Few vacancies in the following location:|
Silver Spring, MD United StatesView Map
WHO MAY APPLY:
|Career or Career-Conditional employees within the Office of New Drugs (OND)|
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 position in located in the Center for Drug Evaluation Research (CDER), Office of New Drugs (OND), Office of Hematology & Oncology Products (OHOP), Division of Hematology Oncology Toxicology (DHOT) located in Silver Spring, MD.
Who May Apply: This vacancy is open to current Office of New Drugs (OND) employees with competitive status only. Competitive status refers to employees who are serving on a career or career conditional appointment.
YOU MUST SUBMIT YOUR SF-50 (AND DD-214 IF APPLICABLE).
This announcement may be used to fill multiple positions in multiple locations.
- U.S. Citizenship is required.
- Current SF-50
DUTIES:Back to top
Reviews and evaluates scientific submissions focusing on non-clinical in vitro and animal data and evaluation of toxicological potential of drugs in support of proposed clinical studies or proposed dosage regimens in the labeling.
The incumbent develops comments on labeling as it pertains to animal studies and probable safety in use of the drug for the proposed indications and at the recommended dosage.
Reviews and evaluates the results of non-clinical pharmacological and toxicological studies submitted by the drug sponsor/applicant in support of INDs, NDAs, BLAs amendments, supplements and other related scientific submissions to assess the safety of the drug based on toxicity experiments conducted by the applicant.
Prepares comprehensive summaries and integrated discussions of data submitted for reivew and other available information. Submits substantive regulatory recommendations and conclusions for concurrence by the scientific supervisor.
Meets with industry representatives to exchange information and to provide advice and guidance regarding those aspects of the application, notice, amendment, supplement or report which fall within area of review, with emphasis on non-clinical studies to support clinical studies or NDA or BLAs, as well as deficiencies in animal studies.
QUALIFICATIONS REQUIRED:Back to top
For the GS-14, in addition to the basic education requirement, you must have one year of specialized experience equivalent to the next lower grade in the Federal Service. Examples of specialized experience at the next lower grade would consist of skills to identify and understand the most difficult, complex, and broad Agency regulatory issues; experience interpreting, evaluating and explaining pharmacological/toxicological data/regulations and policies.
Degree: major in an appropriate biological, medical, veterinary, or physical science, or in pharmacy that included at least 30 semester hours in chemistry and physiology and 12 semester hours in pharmacology.
Conditions of Employment:
1. Additional Security and Background Requirements: May be referred depending on the position being filled. If not previously completed, a background security investigation will be required for all appointees. 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. In addition, 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 appropriate disciplinary action.
2. All qualification requirements must be met by the closing date of the announcement.
3. Financial disclosure statement may be required.
4. Travel, transportation, and relocation expenses will be paid: No
5. Bargaining Unit Position: Yes
6. Drug Screening Required: No
7. Recruitment Bonus may be authorized: No
8. Research position: No
9. Supervisory position: No
10. Time in grade (TIG) must be met within 30 days of the closing date of the announcement.
HOW YOU WILL BE EVALUATED:
Once the application process is complete, a review of the resume 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 qualifications and/or experience, you may lose consideration for this position. Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Your qualifications will be evaluated and rated on the following competencies (knowledge, skills, abilities and other characteristics):
1. Knowledge of the broad fields of pharmacology and toxicology.
2. Ability to supervise a team.
3. Ability to communicate orally.
4. Ability to communicate in writing.