Pharmacologist
Company Name:
Department Of Health And Human Services
United States Citizens Permanent Full Time
The Food and Drug Administration - Protecting and Promoting _Your___Health
Help protect public health by joining the FDA''s Center for Devices & Radiological Health (CDRH). From reviewing applications for innovative medical devices to educating industry on relevant policies and regulations to providing accurate, science-based health information to the public, CDRH is at the forefront in ensuring the safety, efficacy, and security of the medical devices and radiation-emitting products that millions of Americans use daily.
This position is located within CDRH''s Office of Device Evaluation.
One or more positions may be filled using this vacancy announcement.
You must be a U.S. citizen or national to apply for this position. This position is subject to peer review prior to final selection.
As a Pharamacologist, you will serve as the resident expert on the pharmacology/biocompatibility of medical devices. Specific duties include:
Serving as the Agency spokesperson and authoritative source of information on pharmacology/biocompatibility issues related to the evaluation of medical devices and combination products;
Recommending and developing Agency policies and international and nationwide standards, procedures, and instructions related to the regulation of medical devices;
Leading the review off manufacturer data to determine if a decision on the safety and effectiveness of a device can be made or if more information is needed;
Incorporating the latest developments in the fields of toxicology and biocompatibility into Agency programs and policies; and
Providing oversight on a branch level of the periodic review of complex periodic reports of clinical experiences, studies, and tests submitted by manufacturers
In order to be qualified for this position, you must possess:
a Bachelor''s or higher degree with a 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. (Evaluation of Education: Courses in chemistry, organic chemistry, biochemistry, general physiology, and animal, human, microbial, or cellular physiology may be used to meet the 30-semester-hour requirement in chemistry and physiology. Under some circumstances, i.e., where the course work provided additional insight into the biophysical, biochemical, and physiological relationships involved, courses in such subjects as cytology, embryology, cellular or microbial genetics, and biophysics may be used to meet this requirement. Courses in pharmacology, pharmacodynamics, pharmacotherapeutic, molecular pharmacology, and other similar subjects may be used to meet the 12-semester-hour requirement in pharmacology. Courses dealing intensively with pharmacologically-oriented subjects may also be used to meet this requirement.) AND
one year of specialized experience equivalent to the GS-14 level in the Federal service overseeing the review or evaluation of medical devices to determine their efficacy and safety; resolving precedent-setting technical problems or questions encountered by scientists/researchers during the review or evaluation of the accuracy, reliability, or safety of medical devices; independently planning pharmacological studies, including identifying topics to be investigated and the methods to be used; and delivering presentations at national conferences or meetings to industry representatives, senior managers, or researchers from other organizations on scientific or regulatory issues.
This position requires specific coursework and/or a degree to meet the basic education requirement. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.Your transcript(s) must clearly demonstrate the course(s) listed in the qualification requirement section. If the transcript(s) does not clearly demonstrate this you must submit a copy of the course description and/or other documentation demonstrating that the courses are equivalent. Degree requirements must be met within 30 days of the closing date of this job announcement and your transcript(s) submitted must reflect this.
Foreign Education: 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 onforeign education
All qualification requirements, other than education, must be met by 11:59 PM (Eastern Time) on the closing date of this vacancy announcement. Degree/coursework requirements (if applicable) must be met within 30 days of the close of the announcement.
Failure to provide any of the above will result in an ineligible rating.
Conditions of Employment:
1. Security and Background Requirements: 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. E-Verify: If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS 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. Financial disclosure statement may be required.
5. One-year probationary period may be required.
6. Travel, transportation, and relocation expenses will be paid: No
7. Bargaining Unit Position: No
8. Drug Screening Required: No
9. Recruitment incentives may be authorized: No
10. Student loan repayment incentive authorized: No
11. Annual leave for non-federal service authorized: No
Once the application process is complete, a review of the best-qualified applications will be conducted. The r sum and supporting documentation will be compared against the applicant''s responses to the assessment questionnaire to determine if the applicant is qualified for this job. If, after reviewing the applicant''s r sum and supporting documentation, a determination is made that the applicant has inflated his/her qualifications and/or experience, the applicant may lose consideration for this position and/or the applicant''s score may be adjusted to more accurately reflect his/her skills and abilities. Please follow all instructions carefully. Errors or omissions may affect your eligibility.
For Competitive Applicants/All U.S. Citizens: Eligible candidates will be assigned to a quality category: Best Qualified, Well Qualified or Qualified. Candidates in the highest category will be referred to the hiring agency. The Category Rating process does not add veterans'' 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-09 level or higher.)
Your qualifications will be evaluated against the following competencies (knowledge, skills, abilities, and other characteristics):
Technical Knowledge - Pharmacology/Biocompatibility
Technical Knowledge - Medical Device Development and Evaluation
Program Management
Oral Communication
The complete Application Package must be submitted by 11:59 PM (EST) onFriday, May 23, 2014
To begin the process , click the Apply Online button to create an account or log in to your existing USAJOBS account. Follow the prompts to select your USAJobs resume and/or other supporting documents and complete the assessment questionnaire. Please ensure you click the Submit My Answers button at the end of the process.
To verify your application is complete , log into your USAJobs account ( ) and select the Application Status link. Then, select the More Information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process.
To return to an incomplete application , log into your USAJobs account and click Update Application in the vacancy announcement. You must re-select your resume and/or other documents from your USAJobs account or your application will be incomplete.
To fax supporting documents you are unable to upload, complete this cover using the following Vacancy ID:1117798. Fax your documents to .
If you cannot apply online:
1. Click the following link to view and print the assessment questionnaire View Occupational Questionnaire, and
2. Print this 1203FX form to provide your response to the assessment and
3. Fax the completed 1203FX form along with any supporting documents to . Your 1203FX will serve as a cover page for your fax transmission
The following documents are required and must be received by the closing date of this announcement:
1. Your R sum : _Resumes should include full description of job duties as well as dates (mm/yr) of employment_2. A complete Assessment Questionnaire
3. Other supporting documents:
Veterans Preference Documentation, if applicable
College transcript(s)
CTAP/ICTAP documentation, if applicable
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 government offers a comprehensive benefits package. Explore the major benefits offered to most Federal employees .
Veterans'' Preference: If you are a veteran claiming 5-point veterans'' preference, you must submit a copy of your DD-214 (Member Copy 4) or an official statement (including Character of Service) from your command if currently on active duty. If you are claiming 10-point veterans'' preference, in addition to the DD-214, you must also submit aStandard Form 15 (Application for 10-Point Veteran Preference) and the required supporting documents listed on that form. For more information on veterans'' preference / .
Career Transition Assistance Programs: This program applies to Federal workers whose positions have been deemed ''surplus'' or no longer needed, or an employee 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''. For information on how to apply and what documents to submit as an CTAP/ICTAP eligible, go #ictap. Candidates must meet or exceed the Well-Qualified category (85) to be considered as a CTAP/ICTAP eligible.
Selective Service: The Defense Authorization Act of 1986 requires that all male applicants born after 12/31/59 who are required to register under the Military Selective Service Act, be registered or they are not eligible for appointment to this position. For further information concerning Selective Service requirements, please /.Estimated Salary: $20 to $28 per hour based on qualifications.
Department Of Health And Human Services
United States Citizens Permanent Full Time
The Food and Drug Administration - Protecting and Promoting _Your___Health
Help protect public health by joining the FDA''s Center for Devices & Radiological Health (CDRH). From reviewing applications for innovative medical devices to educating industry on relevant policies and regulations to providing accurate, science-based health information to the public, CDRH is at the forefront in ensuring the safety, efficacy, and security of the medical devices and radiation-emitting products that millions of Americans use daily.
This position is located within CDRH''s Office of Device Evaluation.
One or more positions may be filled using this vacancy announcement.
You must be a U.S. citizen or national to apply for this position. This position is subject to peer review prior to final selection.
As a Pharamacologist, you will serve as the resident expert on the pharmacology/biocompatibility of medical devices. Specific duties include:
Serving as the Agency spokesperson and authoritative source of information on pharmacology/biocompatibility issues related to the evaluation of medical devices and combination products;
Recommending and developing Agency policies and international and nationwide standards, procedures, and instructions related to the regulation of medical devices;
Leading the review off manufacturer data to determine if a decision on the safety and effectiveness of a device can be made or if more information is needed;
Incorporating the latest developments in the fields of toxicology and biocompatibility into Agency programs and policies; and
Providing oversight on a branch level of the periodic review of complex periodic reports of clinical experiences, studies, and tests submitted by manufacturers
In order to be qualified for this position, you must possess:
a Bachelor''s or higher degree with a 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. (Evaluation of Education: Courses in chemistry, organic chemistry, biochemistry, general physiology, and animal, human, microbial, or cellular physiology may be used to meet the 30-semester-hour requirement in chemistry and physiology. Under some circumstances, i.e., where the course work provided additional insight into the biophysical, biochemical, and physiological relationships involved, courses in such subjects as cytology, embryology, cellular or microbial genetics, and biophysics may be used to meet this requirement. Courses in pharmacology, pharmacodynamics, pharmacotherapeutic, molecular pharmacology, and other similar subjects may be used to meet the 12-semester-hour requirement in pharmacology. Courses dealing intensively with pharmacologically-oriented subjects may also be used to meet this requirement.) AND
one year of specialized experience equivalent to the GS-14 level in the Federal service overseeing the review or evaluation of medical devices to determine their efficacy and safety; resolving precedent-setting technical problems or questions encountered by scientists/researchers during the review or evaluation of the accuracy, reliability, or safety of medical devices; independently planning pharmacological studies, including identifying topics to be investigated and the methods to be used; and delivering presentations at national conferences or meetings to industry representatives, senior managers, or researchers from other organizations on scientific or regulatory issues.
This position requires specific coursework and/or a degree to meet the basic education requirement. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.Your transcript(s) must clearly demonstrate the course(s) listed in the qualification requirement section. If the transcript(s) does not clearly demonstrate this you must submit a copy of the course description and/or other documentation demonstrating that the courses are equivalent. Degree requirements must be met within 30 days of the closing date of this job announcement and your transcript(s) submitted must reflect this.
Foreign Education: 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 onforeign education
All qualification requirements, other than education, must be met by 11:59 PM (Eastern Time) on the closing date of this vacancy announcement. Degree/coursework requirements (if applicable) must be met within 30 days of the close of the announcement.
Failure to provide any of the above will result in an ineligible rating.
Conditions of Employment:
1. Security and Background Requirements: 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. E-Verify: If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS 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. Financial disclosure statement may be required.
5. One-year probationary period may be required.
6. Travel, transportation, and relocation expenses will be paid: No
7. Bargaining Unit Position: No
8. Drug Screening Required: No
9. Recruitment incentives may be authorized: No
10. Student loan repayment incentive authorized: No
11. Annual leave for non-federal service authorized: No
Once the application process is complete, a review of the best-qualified applications will be conducted. The r sum and supporting documentation will be compared against the applicant''s responses to the assessment questionnaire to determine if the applicant is qualified for this job. If, after reviewing the applicant''s r sum and supporting documentation, a determination is made that the applicant has inflated his/her qualifications and/or experience, the applicant may lose consideration for this position and/or the applicant''s score may be adjusted to more accurately reflect his/her skills and abilities. Please follow all instructions carefully. Errors or omissions may affect your eligibility.
For Competitive Applicants/All U.S. Citizens: Eligible candidates will be assigned to a quality category: Best Qualified, Well Qualified or Qualified. Candidates in the highest category will be referred to the hiring agency. The Category Rating process does not add veterans'' 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-09 level or higher.)
Your qualifications will be evaluated against the following competencies (knowledge, skills, abilities, and other characteristics):
Technical Knowledge - Pharmacology/Biocompatibility
Technical Knowledge - Medical Device Development and Evaluation
Program Management
Oral Communication
The complete Application Package must be submitted by 11:59 PM (EST) onFriday, May 23, 2014
To begin the process , click the Apply Online button to create an account or log in to your existing USAJOBS account. Follow the prompts to select your USAJobs resume and/or other supporting documents and complete the assessment questionnaire. Please ensure you click the Submit My Answers button at the end of the process.
To verify your application is complete , log into your USAJobs account ( ) and select the Application Status link. Then, select the More Information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process.
To return to an incomplete application , log into your USAJobs account and click Update Application in the vacancy announcement. You must re-select your resume and/or other documents from your USAJobs account or your application will be incomplete.
To fax supporting documents you are unable to upload, complete this cover using the following Vacancy ID:1117798. Fax your documents to .
If you cannot apply online:
1. Click the following link to view and print the assessment questionnaire View Occupational Questionnaire, and
2. Print this 1203FX form to provide your response to the assessment and
3. Fax the completed 1203FX form along with any supporting documents to . Your 1203FX will serve as a cover page for your fax transmission
The following documents are required and must be received by the closing date of this announcement:
1. Your R sum : _Resumes should include full description of job duties as well as dates (mm/yr) of employment_2. A complete Assessment Questionnaire
3. Other supporting documents:
Veterans Preference Documentation, if applicable
College transcript(s)
CTAP/ICTAP documentation, if applicable
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 government offers a comprehensive benefits package. Explore the major benefits offered to most Federal employees .
Veterans'' Preference: If you are a veteran claiming 5-point veterans'' preference, you must submit a copy of your DD-214 (Member Copy 4) or an official statement (including Character of Service) from your command if currently on active duty. If you are claiming 10-point veterans'' preference, in addition to the DD-214, you must also submit aStandard Form 15 (Application for 10-Point Veteran Preference) and the required supporting documents listed on that form. For more information on veterans'' preference / .
Career Transition Assistance Programs: This program applies to Federal workers whose positions have been deemed ''surplus'' or no longer needed, or an employee 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''. For information on how to apply and what documents to submit as an CTAP/ICTAP eligible, go #ictap. Candidates must meet or exceed the Well-Qualified category (85) to be considered as a CTAP/ICTAP eligible.
Selective Service: The Defense Authorization Act of 1986 requires that all male applicants born after 12/31/59 who are required to register under the Military Selective Service Act, be registered or they are not eligible for appointment to this position. For further information concerning Selective Service requirements, please /.Estimated Salary: $20 to $28 per hour based on qualifications.
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