Job Title: Senior Clinical AnalystJob Announcement Number: HHS-FDA-MP-13-938960
Department: Department Of Health And Human Services
Agency: Food and Drug Administration
This position is closed and no longer accepting online applications through USAJOBS.
The contents of the announcement can still be viewed.
/ Per Year
Monday, August 12, 2013 to
Friday, August 23, 2013
SERIES & GRADE:
Full Time -
Few vacancies in the following location:
Silver Spring, MD United StatesView Map
WHO MAY APPLY:
Career Conditional/Career employees within the Office of New Drugs
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 is located in the Center for Drug Evaluation & Reserarch (CDER), Office of New Drugs (OND), Office of Antimicrobial Products (OAP), Divison of Antiviral Products (DAP) located at the White Oak Campus in Silver Spring, MD.
Who May Apply: Current OND employees only, with career or career conditional appointments in the competitive service;
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.
- Must submit most recent SF-50
- Must provide transcripts.
DUTIES:Back to top
Review and evaluate clinical study protocol and reports submitted in BLAs, NDAs, supplemental; new INDs, new protocols and protocol amendments.
Evaluate development plans and study protocols to determine the safety of designs and the ability to generate evidence of effectiveness.
Review and evaluate reports of clinical trials to determine if the data are adequate and well controlled, and sufficient to support the efficacy and safety of the drug under investigation.
Participate in coordinating initiatives and activities related to the program and the implementation of regulations and guidance.
Coordinate with other CDER offices on complex regulatory issues and keeps abreast of crucial and precedent-setting cases within agency.
QUALIFICATIONS REQUIRED:Back to top
I. Basic Requirement:
A. Basic Requirement for GS-601 Senior Clinical Analyst: Degree in a major study in an academic field related to the health sciences or allied sciences appropriate to the work of the position.
Transcripts must be submitted at time of application of submission to support education requirements.
II. Specialized Experience Requirement:
GS-14: Have one year of specialized experience, equivalent to the GS-13 level in the Federal service, demonstrating use of regulations and procedures involved in the product and drug development and review process; participating in the management and coordination of scientific projects and initiatives as well as planning, focusing and coordinating of the teams activities.
In addition to the basic requirements applicants must have one year of specialized experience at the next lower grade in the Federal Service. Specialized experience at the GS-13 level in the Federal Service are as follows: providing authoriative advice and guidance on all aspects of prescription drug product labeling review and approval. Reviewing USPI to help ensure it conforms to labeling regulations, assisting in facilitation of labeling meetings, and monitoring development of labeling New Drug Applications.
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 scientific, clinical, and medical regulations pertinent to program.
2. Ability to communicate orally.
3. Abiltiy to communicate in writing.