This position is located in the Department of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Unapproved Drug & Labeling Compliance (OUDLC), located in Silver Spring, MD.
Summary
This position is located in the Department of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Unapproved Drug & Labeling Compliance (OUDLC), located in Silver Spring, MD.
Develop policies and programs involving complex and high priority matters affecting the regulations of drug products.
Utilize resources such as Westlaw, LexisNexis, MediRegs, the US Code, the Code of Federal Regulations, the Federal Regulation.
Conduct research regarding established precedents in order to develop and support legally sufficient regulations, citizens? petition responses, and policies.
Participate on working groups of scientific, regulatory and legal experts to develop new or revised regulations and draft the resulting notices of proposed rulemaking.
Prepare replies to correspondence from the regulated community, Congress, and other interested persons on issues that are industry-wide in scope.
Draft and comment on proposed legislation on matters pertaining to FDA?s jurisdiction.
Consult with appropriate scientific experts and drafts responses to citizen petitions, petitions for stay of action, and/or petitions for reconsideration.
Advise staff in the Office of Chief Counsel and other offices in the Office of Commissioner on matters related to the Regulatory Counsel?s responsibilities.
Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
Selective Service Registration: All males born on, or after, 12/31/1959, must be registered with the Selective Service System OR have an approved exemption. VIsit www.SSS.gov for more info.
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.
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.
You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. You must continue to meet all requirements through the hiring process.
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.
Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
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.
Qualifications
Minimum Qualifications:
The position of Regulatory Counsel falls under the 0301 occupational series. To qualify for this position at grade GS-13, you must meet the following:One year specialized experience to the GS-12 grade level in the Federal Service that has equipped me with the particular skills, knowledge, and ability to successfully perform the duties of the position. Such experience on providing advice on statutes and regulations; writing legal documents such as legal memoranda for a regulatory or compliance program; leading working groups of regulatory, scientific, and legal experts to develop recommendations to regulatory and scientific issues; and presenting regulatory information meetings.
This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-18-MP-10293010 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.
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:
If you are serving, or have served in the last 5 years (from 10/11/2018) 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. Political Appointee FAQ - OPM
Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.
Pre-Employment Physical: No
Drug Testing Requirement: No
License Requirement: No
Immunization Requirement: No
Mobility Agreement Required: No
Bargaining Unit Position: Yes
Veteran's Preference: If you plan to apply for any time of Veterans Preference, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. See Veterans Preference for more.
Selective Service Registration: Males born after December 31, 1959 must be registered or exempt from Selective Service. You can learn more by visiting the Selective Service Registration site.
Schedule A: If you plan to apply under Schedule A based on a disability, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. See Individuals with Disabilities for more.
Career Transition Assistance Programs: If you are a displaced Federal employee and plan to apply under CTAP or ICTAP, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. See Career Transition Assistance for more.
Financial disclosure statement, OGE-450, required: Please be advised that this position will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers.
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 Eastern Time on 10/11/2018), a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for Federal employment, and then whether you are qualified for this particular position.
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 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 30 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 need not respond to the KSA's directly, but your resume should contain sufficient information to demonstrate possession of the Competencies.? To preview the application assessment questions, click the link below: https://apply.usastaffing.gov/ViewQuestionnaire/10293012
1. Technical Competence- Regulatory Counsel
2. Planning and Evaluation
3. Ability to write clearly and logically on complex issues
4. Ability to communicate orally
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.
The following documents are REQUIRED for this vacancy:
Resume
"Required" indicates that the above documents are necessary to determine your eligibility and/or qualification for this vacancy. These documents are collected from ALL applicants and failing to provide any of these documents may result in your application being deemed incomplete or ineligible. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application. If you need instructions or assistance with submitting documentation, please see the Applicant Help Site - Documents page for more information.
RESUME REQUIREMENTS:
The Federal Government has very specific requirements for the information that you must include in your resume. A resume for a Federal job will be much longer and more detailed than the type of resume you may be familiar with from the private sector, especially if you're accustomed to submitting in CV (curriculum vitae) format. If you have not written a Federal resume before, you may want to 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, you should include: start and end dates for each position (including month and year), number of hours per week worked, level of experience and duties performed, employer name and address, supervisor name and contact, and salary (or grade and step), for each position listed in your work history.
The following documents are ACCEPTED for this vacancy:
DD-214
Other
Other Veterans Document
Resume
SF-15
SF-50
"Accepted" means that you will have the opportunity to submit these documents, if they are applicable to you. Such documents include Veteran Preference or other special eligibility documentation, transcripts, or other optional documentation that helps us determine your eligibility. The above list of documents may not apply to all applicants. If you are unsure what documents might apply to you, please review the USAJOBS FAQ article: "What types of documents might I need to provide?" or contact the FDA Applicant Help Desk.
ADDITIONAL DOCUMENTATION REQUIREMENTS FOR APPLICANTS WHO WISH TO APPLY FOR SPECIAL APPOINTING AUTHORITIES:
Veterans: veteran eligibility documentation, including DD-214 Member #4 Copy, VA Letter, Standard Form (SF)-15, vary based on what preference you claim. If you are a veteran who has not yet been discharged, you may provide a statement of intent to discharge from your agency to receive Veterans Preference under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011. Learn more about Veterans Preference and documentation requirements on the USAJOBS Help Site for Veterans.
Individuals with Disabilities: Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities may apply for appointment through the Schedule A hiring authority. Certified verification of a disability from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required. You can learn more about this appointment type on the USAJOBS Help Center page for Individuals with Disabilities.
Displaced Federal employees who qualify for CTAP/ICTAP: If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. Please see the USAJOBS Help Site page for Career Transition for more information.
If you are relying on your education to meet qualification requirements:
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 the "Apply Online" button. See the USAJOBS Help 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, 10/11/2018. 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 deadline, and in most cases, only experience and education obtained by this date will be considered.
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 you encounter any difficulty with the site, we recommend that you visit 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-mailQuickQuestions@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) 10293012 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 your application 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 strive to make selections within 45 days of the closing date of this announcement (10/11/2018). You will receive application status updates via email and via USAJOBS as the process unfolds. How to check your application status and understand what each status means.
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
The following documents are REQUIRED for this vacancy:
Resume
"Required" indicates that the above documents are necessary to determine your eligibility and/or qualification for this vacancy. These documents are collected from ALL applicants and failing to provide any of these documents may result in your application being deemed incomplete or ineligible. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application. If you need instructions or assistance with submitting documentation, please see the Applicant Help Site - Documents page for more information.
RESUME REQUIREMENTS:
The Federal Government has very specific requirements for the information that you must include in your resume. A resume for a Federal job will be much longer and more detailed than the type of resume you may be familiar with from the private sector, especially if you're accustomed to submitting in CV (curriculum vitae) format. If you have not written a Federal resume before, you may want to 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, you should include: start and end dates for each position (including month and year), number of hours per week worked, level of experience and duties performed, employer name and address, supervisor name and contact, and salary (or grade and step), for each position listed in your work history.
The following documents are ACCEPTED for this vacancy:
DD-214
Other
Other Veterans Document
Resume
SF-15
SF-50
"Accepted" means that you will have the opportunity to submit these documents, if they are applicable to you. Such documents include Veteran Preference or other special eligibility documentation, transcripts, or other optional documentation that helps us determine your eligibility. The above list of documents may not apply to all applicants. If you are unsure what documents might apply to you, please review the USAJOBS FAQ article: "What types of documents might I need to provide?" or contact the FDA Applicant Help Desk.
ADDITIONAL DOCUMENTATION REQUIREMENTS FOR APPLICANTS WHO WISH TO APPLY FOR SPECIAL APPOINTING AUTHORITIES:
Veterans: veteran eligibility documentation, including DD-214 Member #4 Copy, VA Letter, Standard Form (SF)-15, vary based on what preference you claim. If you are a veteran who has not yet been discharged, you may provide a statement of intent to discharge from your agency to receive Veterans Preference under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011. Learn more about Veterans Preference and documentation requirements on the USAJOBS Help Site for Veterans.
Individuals with Disabilities: Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities may apply for appointment through the Schedule A hiring authority. Certified verification of a disability from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required. You can learn more about this appointment type on the USAJOBS Help Center page for Individuals with Disabilities.
Displaced Federal employees who qualify for CTAP/ICTAP: If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. Please see the USAJOBS Help Site page for Career Transition for more information.
If you are relying on your education to meet qualification requirements:
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 the "Apply Online" button. See the USAJOBS Help 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, 10/11/2018. 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 deadline, and in most cases, only experience and education obtained by this date will be considered.
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 you encounter any difficulty with the site, we recommend that you visit 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-mailQuickQuestions@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) 10293012 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 your application 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 strive to make selections within 45 days of the closing date of this announcement (10/11/2018). You will receive application status updates via email and via USAJOBS as the process unfolds. How to check your application status and understand what each status means.
Fair and transparent
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
