This position is being announced as a Pharmacist, GS-0660-11/12/13/14. The full performance level of each selection will be determined by the Center. This Direct-Hire position is in the Food and Drug Administration, with multiple locations throughout the U.S. and its territories.
Note: Salaries may vary based on the actual location you are hired. You can reference OPM's 2019 General Schedule Pay Tables site to see the current locality-adjusted salary rates for any region.
Summary
This position is being announced as a Pharmacist, GS-0660-11/12/13/14. The full performance level of each selection will be determined by the Center. This Direct-Hire position is in the Food and Drug Administration, with multiple locations throughout the U.S. and its territories.
Note: Salaries may vary based on the actual location you are hired. You can reference OPM's 2019 General Schedule Pay Tables site to see the current locality-adjusted salary rates for any region.
This position is being advertised under a OPM government-wide Direct Hire issued on October 11, 2018 for Scientific, Technical, Engineering and Mathematics (STEM) and cyber-security related positions nationwide. All U.S. Citizens may apply.
Reviewing, evaluating, and contributing to decisions on the approvability of regulatory submissions and applications for new drugs, generic drugs, and studies submitted for consideration.
Assesses the analyses, studies, and recommendations in the therapeutic area for which the reviewer is responsible for scientific validity and for potential influence on organizational objectives and program goals of the Division, Office or Center.
Applies knowledge of the design and analysis of human pharmacokinetic and pharmacodynamic studies to reviews and evaluations of approvability of regulatory submissions.
Stays abreast of complex, long-range, and emerging problems of drug safety, efficacy and dosing and conflicts in the therapeutic area as applied to the products being regulated.
Meets with representatives of the regulated industry to discuss particular problems pertaining to the specific therapeutic area, and maintains clear communication in these meetings.
Additional selections may be made from this vacancy, within the same geographical area, by other organizational elements from within FDA, through shared corporate recruiting activities. Your application may be shown to multiple hiring offices.
Note: The full performance level of each selection will be determined by the Center.
This is a Direct-Hire advertisement: Veterans Preference is not applicable to this advertisement. Learn more about Direct-Hire at https://www.opm.gov/policy-data-oversight/hiring-information/competitive-hiring/#url=directhire ...
This position may be subject to completion of a 1-year probationary period (unless you have already satisfied this obligation).
Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement.
Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
Research Positions may require evaluation of the scientific contributions, recognition, and professional standing of the researcher, and may be subject to peer review. A writing sample or publication portfolio may also be required.
If you were born male, after, December 31st 1959, you must be registered with the Selective Service System, or have an approved exemption. Learn more at www.SSS.gov.
You may be asked to provide additional information at a later time. All interviews requests and selection decisions are at the full discretion of the hiring office.
Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
Qualifications
BASIC QUALIFICATIONS:
In order be eligible for the position of Pharmacist, (GS-0660-11/12/13/14), you must meet the following requirements...
Individual Occupational Requirements:
Basic Requirements
Education - A doctoral degree in Pharmacy that is recognized by the Accreditation Council for Pharmacy Education (ACPE) or an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained. (Must provide transcript(s) at the time of application submission).
Licensure - Applicants must be licensed to practice pharmacy in a State, the District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States. (Must provide copy of Pharmacy license at the time of application submission).
Medical Requirements - Applicants must be able to distinguish basic colors.
In addition to meeting the basic qualifications, you must also meet the minimum qualifications below...
MINIMUM QUALIFICATIONS REQUIREMENTS: GS-11: Applicants must have a Ph.D, Pharm.D. or equivalent doctoral degree or three years of progressively higher level graduate education leading to a Ph.D. degree.
GS-12: You must possess one year (52-weeks) of specialized experience, equivalent to at least the next lower grade level GS-11 in the Federal service. Such experience includes: providing information to health practitioners and patients about proper usage of medications and side effects; assessing medication use patterns and outcomes for patients; examining the requirement of programs in the pharmacy fields for involvement or consults; and researching drugs information to provide responses to inquiries.
GS-13: You must possess one year (52-weeks) of specialized experience, equivalent to at least the next lower grade level GS-12 in the Federal service. Such experience includes: evaluating pharmacy program standards to ensure compliance with regulatory and accreditation requirements; researching medical literature and/or clinical medication information to provide responses to inquiries; and providing consultation, advice, and guidance on regulatory and compliance issues in the pharmacy field
GS-14: You must possess one year (52-weeks) of specialized experience, equivalent to at least the next lower grade level GS-13 in the Federal service. Such experience includes: providing consultation, advice, and guidance on regulatory and compliance issues in the pharmacy field; drafting and evaluating reports of clinical trials and studies in humans for evidence of effectiveness of selected drug applications; and performing administrative, consultative, or staff advisory work for a medical facility's pharmacy program.
NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date. To verify your application is complete, log into your USAJOBS account, https://my.usajobs.gov/Account/Login, select the Application Status link and 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.
IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume.
All qualification requirements must be met by 11:59 pm (Eastern Time) on 05/01/2019. 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.
Education
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; or full credit has been given for the courses at a U.S. accredited college or university. For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.
Additional information
Additional Conditions of Employment:
Pre-employment physical required: No
Drug testing required: No
License required: Yes, Applicants must be licensed to practice pharmacy in a State, the District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States.
Mobility agreement required: No
Immunization required: No
Bargaining Unit Position: Yes, 3591
Financial disclosure statement, OGE-450, required: Please be advised that this position may be subject to FDA's prohibited financial interest regulation and may require the incumbent of this position to divest of certain financial interests. Applicants are advised to seek additional information on this requirement from the hiring official before accepting this position.
Additional Information:
Direct-Hire Authority: On October 11th, 2018, the Office of Personnel Management (OPM) issued a special government-wide Direct Hire Authority (DHA) for Scientific, Technical, Engineering, and Mathematics (STEM), and cyber security-related positions nationwide. This position is open to all U.S. Citizens and all qualified candidates will be referred for consideration. The hiring manager may select from any of these qualified candidates without regard to veteran's preference. Learn more about Direct-Hire on OPM's website...
Veterans Preference: Veterans Preference does not apply to this advertisement because it falls under the aforementioned DHA.
Selective Service Registration: If you were born male, after, December 31, 1959, you must be registered with the Selective Service System, or have an approved exemption. Learn more at www.SSS.gov...
If you are serving, or have served in the last 5 years (from 05/01/2019) 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. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. See Political Appointee FAQ - OPM for more...
Reasonable Accommodation: This agency provides reasonable accommodation to applicants with disabilities. If you need a reasonable accommodation for any part of the application and hiring process, please contact the Bethesda Center Help Desk (888) 478-4340; TTY/TDD: (866) 539-4484; or by email quickquestions@fda.hhs.gov. The decision on granting reasonable accommodation will be made on a case-by-case basis. See the Reasonable Accommodation Policy for more information...
Equal Employment Opportunity: The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor See the EEO Policy for more information...
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
How you will be evaluated
You will be evaluated for this job based on how well you meet the qualifications above.
Once the job opportunity announcement closes (at 11:59 pm ET on 05/01/2019), your resume and all supporting documents will be reviewed by HR to determine your eligibility for Federal employment and your qualification for this position specifically.
Because this vacancy will be filled through OPM's Direct Hire Authority, Veterans Preference and traditional rating and ranking of applicants do NOT apply to positions filled under this announcement. Applications received as a result of job fairs, recruitment events, and emergency hiring mechanisms in support of this hiring initiative will also be accepted during the duration of the direct-hire authority. All qualified candidates will be referred for consideration; the hiring office may conduct interviews at their discretion.
Please follow all instructions carefully. Errors or omissions may affect your eligibility.
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
A document that is required must be submitted by all applicants because the document is needed to verify your qualifications, education, or other eligibility information. Failure to provide one of the documents in the list below may result in your application being considered incomplete.
Cover Letter
OF-306
Pharmacy License
Resume
SF-50
Transcript
These documents may be required for some applicants. Applicants relying on education to qualify, those seeking consideration under a special hiring authority, or those who need to verify a license or certification, will need to submit appropriate supporting documentation from this list. RESUME REQUIREMENTS:
The federal government has very specific resume requirements. If you have not written a federal resume before, you should watch this Resume Writing Tutorialvideo on the USAJOBS YouTube channel, or read through a helpful Resume Writing FAQ on the USAJOBS Help Site to learn what details you should, and should not, include in your resume.
At a minimum your resume should list the position title, employer, start and end dates (including month and year), salary (or grade and step), hours worked per week, and a list of duties performed or accomplishments, for EACH position listed. A CV (curriculum vitae) may not contain enough information to meet these resume requirements.
Learn more about supporting documents and documentation requirements on USAJOBS:
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.
To apply for positions with the Food & Drug Administration, you must have a USAJOBS Login.GOV account, and be signed in to that account, before you click "Apply Online". See the USAJOBS Help Site article "How does the application process work?" for more on this process. Additionally, you must provide a resume and any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement, 05/01/2019 We recommend that you start the application process early enough that you can complete and submit your application before this deadline. Please note that you cannot submit documentation or make changes to your application after the close date.
If you would like to learn how to use USAJOBS including: accessing and managing your account, adding saved documents, building a resume, or starting an application; we recommend you visit the USAJOBS How To site, and read up on any topic that you need help with. This site is located at: https://www.usajobs.gov/Help/how-to/. Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Help site at: https://www.usajobs.gov/Help/. FDA's Applicant Help Desk is not able to support USAJOBS-related issues.
The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are not familiar with Application Manager or encounter any difficulty with the site, we recommend that you review the Applicant HELP Site at: https://help.usastaffing.gov/Apply/index.php?title=Applicant. This help site contains step-by-step instructions for completing the application process, submitting documentation, and completing questionnaires, and should be very helpful to you!
You are encouraged to apply online. Applying online will allow you to review and track the status of your application. The FDA will provide reasonable accommodation to applicants with disabilities who are not able to apply online. If you need a reasonable accommodation for any part of the application process, please contact the Applicant Help Desk. Decisions on granting a reasonable accommodation will be made on a case-by-case basis.
If after reviewing the USAJOBS and Application Manager help sites, you're not able to find the answer to your question or concern, or if you wish to request a reasonable accommodation, please contact the FDA Applicant Help Desk at 888-478-4340, or e-mail QuickQuestions@fda.gov. The Applicant Help Desk is staffed between the hours of 7am and 6pm Eastern Time, Monday through Friday, except for government holidays. If you contact the Applicant Help Desk, please provide the following Vacancy Identification Number (VIN) 10476714 so that we may assist you faster.
Center for Drug Evaluation and Research
10903 New Hampshire Ave
Silver Spring, MD 20993
US
Next steps
Once you have submitted your complete application, (to include the resume, all required supporting documentation, and the responses to the assessment questionnaires), your application will be reviewed by HR to determine your eligibility and qualification status. If you are referred to the hiring office, they may contact you at their discretion for an interview. If you are not referred, you may not immediately receive a notification due to the high volume of applications that are typically submitted to direct-hire advertisements.
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
A document that is required must be submitted by all applicants because the document is needed to verify your qualifications, education, or other eligibility information. Failure to provide one of the documents in the list below may result in your application being considered incomplete.
Cover Letter
OF-306
Pharmacy License
Resume
SF-50
Transcript
These documents may be required for some applicants. Applicants relying on education to qualify, those seeking consideration under a special hiring authority, or those who need to verify a license or certification, will need to submit appropriate supporting documentation from this list. RESUME REQUIREMENTS:
The federal government has very specific resume requirements. If you have not written a federal resume before, you should watch this Resume Writing Tutorialvideo on the USAJOBS YouTube channel, or read through a helpful Resume Writing FAQ on the USAJOBS Help Site to learn what details you should, and should not, include in your resume.
At a minimum your resume should list the position title, employer, start and end dates (including month and year), salary (or grade and step), hours worked per week, and a list of duties performed or accomplishments, for EACH position listed. A CV (curriculum vitae) may not contain enough information to meet these resume requirements.
Learn more about supporting documents and documentation requirements on USAJOBS:
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.
To apply for positions with the Food & Drug Administration, you must have a USAJOBS Login.GOV account, and be signed in to that account, before you click "Apply Online". See the USAJOBS Help Site article "How does the application process work?" for more on this process. Additionally, you must provide a resume and any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement, 05/01/2019 We recommend that you start the application process early enough that you can complete and submit your application before this deadline. Please note that you cannot submit documentation or make changes to your application after the close date.
If you would like to learn how to use USAJOBS including: accessing and managing your account, adding saved documents, building a resume, or starting an application; we recommend you visit the USAJOBS How To site, and read up on any topic that you need help with. This site is located at: https://www.usajobs.gov/Help/how-to/. Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Help site at: https://www.usajobs.gov/Help/. FDA's Applicant Help Desk is not able to support USAJOBS-related issues.
The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are not familiar with Application Manager or encounter any difficulty with the site, we recommend that you review the Applicant HELP Site at: https://help.usastaffing.gov/Apply/index.php?title=Applicant. This help site contains step-by-step instructions for completing the application process, submitting documentation, and completing questionnaires, and should be very helpful to you!
You are encouraged to apply online. Applying online will allow you to review and track the status of your application. The FDA will provide reasonable accommodation to applicants with disabilities who are not able to apply online. If you need a reasonable accommodation for any part of the application process, please contact the Applicant Help Desk. Decisions on granting a reasonable accommodation will be made on a case-by-case basis.
If after reviewing the USAJOBS and Application Manager help sites, you're not able to find the answer to your question or concern, or if you wish to request a reasonable accommodation, please contact the FDA Applicant Help Desk at 888-478-4340, or e-mail QuickQuestions@fda.gov. The Applicant Help Desk is staffed between the hours of 7am and 6pm Eastern Time, Monday through Friday, except for government holidays. If you contact the Applicant Help Desk, please provide the following Vacancy Identification Number (VIN) 10476714 so that we may assist you faster.
Center for Drug Evaluation and Research
10903 New Hampshire Ave
Silver Spring, MD 20993
US
Next steps
Once you have submitted your complete application, (to include the resume, all required supporting documentation, and the responses to the assessment questionnaires), your application will be reviewed by HR to determine your eligibility and qualification status. If you are referred to the hiring office, they may contact you at their discretion for an interview. If you are not referred, you may not immediately receive a notification due to the high volume of applications that are typically submitted to direct-hire advertisements.
Fair and transparent
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
