FDA
The FDA is responsible for protecting the public health.
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What We Do

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The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

FDA In Their Voices

Working at FDA

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We are actively recruiting for mission-critical medical and science positions to strengthen our public health mission.

We are attending job fairs throughout the United States to promote available positions and recruit applicants.

Career Opportunities at FDA

Pharmacist - Direct Hire
Duties DutiesSummaryPositions are located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA) in Montgomery County, MD, and may be filled in the following Centers: These positions are located throughout the FDA Centers:Center for Biologics & Evaluation Research (CBER) - Regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. To ensure the safety, purity, potency, and effectiveness of biological products.Center for Drug Evaluation & Research (CDER) - Provide regulatory oversight for investigational studies during drug development and making decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products.Center for Devices and Radiological Health (CDRH) - Facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.Center for Food Safety and Applied Nutrition (CFSAN) - Responsible for the safety of the nation's domestically produced and imported foods, cosmetics, drugs, biologics, medical devices, and radiological products.Center for Tobacco Products (CTP) - Set performance standards review premarket applications for new and modified risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions.Office of Regulatory Affairs (ORA) - Inspects regulated products and manufacturers, conducts sample analyses of regulated products and reviews imported products offered for entry into the United States.National Center for Toxicological Research (NCTR) - Provides the field offices with coordinated direction, assistance, and management for investigational activities in international arenas.Center for Veterinary Medicine (CVM) - Conducts research that helps FDA ensure the safety of animal drugs, food for animals, and food products made from animals; and monitors the safety and effectiveness of animal drugs on the market.ResponsibilitiesProvide administrative and technical supervision necessary for accomplishing the work of the unit.Perform the administrative and human resources management functions relative to the staff supervised.Serve as an expert consultant in the planning, monitoring, and administration of inspections, investigations, programs, or projects that encompass the most critical work in the pharmacy field.Provide overall technical insight into the development and management of policies, procedures, and operational schedules necessary for new regulatory requirements, systems, and functions.Collaborate with officials, counterpart government departments or agencies, national and international organizations, the scientific community, and related industries concerning scientific programs and activities.Perform project planning duties, such as concept development, master integration planning, and programming design, taking into account regulatory requirements, feasibility, costs, resources, and economics.Travel RequiredNot required Supervisory status No Promotion Potential 13 Job family (Series)Similar jobs Requirements Requirements Conditions of EmploymentConditions of Employment: Security and Background Requirements: Appointment will be subject to the applicant's successful completion of a background security investigation. Failure to successfully meet these requirements may be grounds for appropriate personnel action. 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 or appropriate disciplinary action.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.Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.Pre-employment physical required: NoDrug testing required: NoLicense required: Yes, Active Pharmacy LicenseMobility agreement required: NoImmunization required: NoBargaining Unit Position: NoIncentives 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.All qualification requirements must be met by 11:59 pm (Eastern Time) on 06/30/2018. QualificationsIn order to qualify for Pharmacist - Direct Hire, 0660, GS - 13, you must meet the following: Applicants must possess the basic education requirement, medical requirement, licensure and pharmacy experience as defined below:Basic Education Requirement: A doctoral degree in Pharmacy that is recognized by the Accreditation Council for Pharmacy Education (external link) (ACPE) or an accrediting body recognized by the U.S. Department of Education (external link) at the time the degree was obtained. (You must submit transcripts with your application).Licensure: All applicants must have passed the North American Pharmacist Licensure Examination (external link) (NAPLEX) and the Multistate Pharmacy Jurisprudence Examination (external link) (MPJE). Applicants also 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. (You must submit a copy of your active unrestricted pharmacy license).Additional Experience: In addition to the licensure and educational requirements described above, a minimum of one year of professional pharmacy experience that is equivalent to at least the next lower grade level. Applicant's qualifications background must demonstrate the knowledge, skills, abilities, and competencies necessary to perform the work of the position. Pharmacy work requires knowledge of the use, clinical effects, and composition of medications, including their chemical, biological, and physical properties. Qualifying professional pharmacy experience may involve, but is not limited to: Dispensing medications prescribed by physicians and other health practitioners and providing information to health practitioners and patients about proper usage of medications and side effects;Evaluating medication use patterns and outcomes for patients in hospitals or managed care organizations;Performing administrative, consultative, or staff advisory work for a medical facility's pharmacy program;Planning, monitoring and evaluating medication programs or regimens;Establishing medication-handling procedures for the storage and preservation of medications;Researching medical literature and/or clinical medication information to provide accurate responses to inquiries;Maintaining all medication records required by law;Medical Requirement: Applicants must be able to distinguish basic colors. Financial disclosure statement, OGE-450, may be required: Please be advised that this position will 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. Education If you are claiming education as any part of your qualifications for this position, you must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. 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 on . Additional informationIf you are serving, or have served in the last 5 years (from 06/30/2018) 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. 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. .Selective Service Registration: Males born after December 31, 1959 must be registered or exempt from Selective Service. You can learn more by visiting the 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. Inter-agency and 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. How You Will Be EvaluatedYou 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 06/30/2018), 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 or not 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. Cut off dates are Monday, April 30, 2018, Thursday, May 31, 2018 and Saturday, June 30, 2018. Applications received after the cut-off dates will receive consideration through the next closing date. Background checks and security clearanceSecurity clearance Required Documents Required DocumentsThe following documents are ACCEPTED for this vacancy:DD-214Active Unrestriced Pharmacy LicenseResumeSF-50Transcript "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 some applicants.The following documents are REQUIRED for this vacancy:Active Unrestriced Pharmacy LicenseResumeTranscript "Required" indicates that the above documents are required to determine your 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 not qualified. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application.DOCUMENTATION REQUIREMENTS FOR APPLICANTS WHO QUALIFY FOR SPECIAL APPOINTING AUTHORITIES:Veterans: (DD-214 Member #4 Copy, VA Letter, Standard Form (SF) 15 as applicable). Please note: 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.Persons with Disabilities: Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities may apply for appointment through the Schedule A hiring authority. 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.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 for more information. If you are relying on your education to meet qualification requirements: Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from . 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. Benefits Benefits 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. . 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 to Apply How to ApplyTo apply for this position, you must complete the assessment questionnaire and submit all documentation specified in the Required Documents section below. To receive consideration for this position you must submit your complete application by 11:59 pm Eastern Time on the closing date of this announcement, which is 06/30/2018.Instructions for applying to this job:You must be signed in to USAJOBS. If you do not have a USAJOBS account, you must first create one before you can applyIf you are signed in, you can tap/click "Apply Online" to begin the process.USAJOBS will ask you to select a resume to submit. We recommend that you submit a USAJOBS Resume Builder formatted resume so that you know you're submitting all the information we will need. You may also submit a resume in the format of your choice. For tips on what to include in your resume, see the USAJOBS site.USAJOBS will then allow you to include documentation from your USAJOBS Saved Documents area. You may also attach additional supporting documents during this stage, or you may wait until you reach Application Manager.You will then be required to respond to certify your application materials and you'll be given the chance to elect to provide demographic information (if you have completed this part of your USAJOBS profile).Finally, you will be transferred to FDA's Application Manager (USA Staffing) system to complete the occupational questionnaire and finalize your application for submission. Follow the on-screen instructions provided and respond to ALL questions presented to you. You will be allowed to finalize and submit additional documents one last time. You will review your application and make final submission. You will then be returned back to USAJOBS.Instructions for reviewing or editing your application:If you need to make a change to your application, or if you just want to know your application status, you will need to be logged in to your USAJOBS account. Tap/click on your name in the top-right corner, then select "Applications".You will see a list of the most recent applications you have submitted. Tap/click on the one you wish to review or edit. The item will expand and provide your current status, along with additional information about that application. If you wish to change something then tap/click the "Update Application" button.You will be taken through the same steps you did when you initially applied. You can make changes to add or remove supporting documents before being transferred over to FDA's Application Manager system where you can continue making changes to your responses to the occupational questionnaire. Step through the process as you did the first time, taking care to make the changes you need, and submitting in the final step.You are encouraged to apply online. Applying online will allow you to review and track the status of your application. 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 Customer HelpDesk at (888) 478-4340; TTY/TDD: (800) 877-8339; or by email . (If you request by e-mail, please replace the blank space in the body with the Vacancy Identification Number, VIN, which is:10178298.) Decisions on granting reasonable accommodation will be made on a case-by-case basis.Agency contact informationFDA Applicant Help Desk FDA Applicant Help Desk PhoneEmailAddress FDA Office of Operations 10903 New Hampshire Ave Silver Spring, MD US Next steps 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 strive to make selections within 45 days of the closing date of this announcement (06/30/2018).You will receive application status updates via email and via USAJOBS as the process unfolds. Fair & Transparent Fair & Transparent The Federal hiring process is setup to be fair and transparent. Please read the following guidance. Equal Employment Opportunity Policy 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. Reasonable Accommodation Policy Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application and hiring process should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis. A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits. Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when: An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job.An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace.An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events. You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis. Learn more about or Legal and regulatory guidance
Pharmacist - Direct Hire
Duties DutiesSummaryPositions are located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA) in Montgomery County, MD, and may be filled in the following Centers: These positions are located throughout the FDA Centers:Center for Biologics & Evaluation Research (CBER) - Regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. To ensure the safety, purity, potency, and effectiveness of biological products.Center for Drug Evaluation & Research (CDER) - Provide regulatory oversight for investigational studies during drug development and making decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products.Center for Devices and Radiological Health (CDRH) - Facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.Center for Food Safety and Applied Nutrition (CFSAN) - Responsible for the safety of the nation's domestically produced and imported foods, cosmetics, drugs, biologics, medical devices, and radiological products.Center for Tobacco Products (CTP) - Set performance standards review premarket applications for new and modified risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions.Office of Regulatory Affairs (ORA) - Inspects regulated products and manufacturers, conducts sample analyses of regulated products and reviews imported products offered for entry into the United States.National Center for Toxicological Research (NCTR) - Provides the field offices with coordinated direction, assistance, and management for investigational activities in international arenas.Center for Veterinary Medicine (CVM) - Conducts research that helps FDA ensure the safety of animal drugs, food for animals, and food products made from animals; and monitors the safety and effectiveness of animal drugs on the market.ResponsibilitiesProvide administrative and technical supervision necessary for accomplishing the work of the unit.Perform the administrative and human resources management functions relative to the staff supervised.Serve as an expert consultant in the planning, monitoring, and administration of inspections, investigations, programs, or projects that encompass the most critical work in the pharmacy field.Provide overall technical insight into the development and management of policies, procedures, and operational schedules necessary for new regulatory requirements, systems, and functions.Collaborate with officials, counterpart government departments or agencies, national and international organizations, the scientific community, and related industries concerning scientific programs and activities.Perform project planning duties, such as concept development, master integration planning, and programming design, taking into account regulatory requirements, feasibility, costs, resources, and economics.Travel RequiredNot required Supervisory status No Promotion Potential 13 Job family (Series)Similar jobs Requirements Requirements Conditions of EmploymentConditions of Employment: Security and Background Requirements: Appointment will be subject to the applicant's successful completion of a background security investigation. Failure to successfully meet these requirements may be grounds for appropriate personnel action. 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 or appropriate disciplinary action.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.Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.Pre-employment physical required: NoDrug testing required: NoLicense required: Yes, Active Pharmacy LicenseMobility agreement required: NoImmunization required: NoBargaining Unit Position: NoIncentives 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.All qualification requirements must be met by 11:59 pm (Eastern Time) on 06/30/2018. QualificationsIn order to qualify for Pharmacist - Direct Hire, 0660, GS - 13, you must meet the following: Applicants must possess the basic education requirement, medical requirement, licensure and pharmacy experience as defined below:Basic Education Requirement: A doctoral degree in Pharmacy that is recognized by the Accreditation Council for Pharmacy Education (external link) (ACPE) or an accrediting body recognized by the U.S. Department of Education (external link) at the time the degree was obtained. (You must submit transcripts with your application).Licensure: All applicants must have passed the North American Pharmacist Licensure Examination (external link) (NAPLEX) and the Multistate Pharmacy Jurisprudence Examination (external link) (MPJE). Applicants also 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. (You must submit a copy of your active unrestricted pharmacy license).Additional Experience: In addition to the licensure and educational requirements described above, a minimum of one year of professional pharmacy experience that is equivalent to at least the next lower grade level. Applicant's qualifications background must demonstrate the knowledge, skills, abilities, and competencies necessary to perform the work of the position. Pharmacy work requires knowledge of the use, clinical effects, and composition of medications, including their chemical, biological, and physical properties. Qualifying professional pharmacy experience may involve, but is not limited to: Dispensing medications prescribed by physicians and other health practitioners and providing information to health practitioners and patients about proper usage of medications and side effects;Evaluating medication use patterns and outcomes for patients in hospitals or managed care organizations;Performing administrative, consultative, or staff advisory work for a medical facility's pharmacy program;Planning, monitoring and evaluating medication programs or regimens;Establishing medication-handling procedures for the storage and preservation of medications;Researching medical literature and/or clinical medication information to provide accurate responses to inquiries;Maintaining all medication records required by law;Medical Requirement: Applicants must be able to distinguish basic colors. Financial disclosure statement, OGE-450, may be required: Please be advised that this position will 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. Education If you are claiming education as any part of your qualifications for this position, you must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. 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 on . Additional informationIf you are serving, or have served in the last 5 years (from 06/30/2018) 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. 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. .Selective Service Registration: Males born after December 31, 1959 must be registered or exempt from Selective Service. You can learn more by visiting the 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. Inter-agency and 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. How You Will Be EvaluatedYou 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 06/30/2018), 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 or not 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. Cut off dates are Monday, April 30, 2018, Thursday, May 31, 2018 and Saturday, June 30, 2018. Applications received after the cut-off dates will receive consideration through the next closing date. Background checks and security clearanceSecurity clearance Required Documents Required DocumentsThe following documents are ACCEPTED for this vacancy:DD-214Active Unrestriced Pharmacy LicenseResumeSF-50Transcript "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 some applicants.The following documents are REQUIRED for this vacancy:Active Unrestriced Pharmacy LicenseResumeTranscript "Required" indicates that the above documents are required to determine your 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 not qualified. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application.DOCUMENTATION REQUIREMENTS FOR APPLICANTS WHO QUALIFY FOR SPECIAL APPOINTING AUTHORITIES:Veterans: (DD-214 Member #4 Copy, VA Letter, Standard Form (SF) 15 as applicable). Please note: 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.Persons with Disabilities: Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities may apply for appointment through the Schedule A hiring authority. 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.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 for more information. If you are relying on your education to meet qualification requirements: Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from . 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. Benefits Benefits 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. . 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 to Apply How to ApplyTo apply for this position, you must complete the assessment questionnaire and submit all documentation specified in the Required Documents section below. To receive consideration for this position you must submit your complete application by 11:59 pm Eastern Time on the closing date of this announcement, which is 06/30/2018.Instructions for applying to this job:You must be signed in to USAJOBS. If you do not have a USAJOBS account, you must first create one before you can applyIf you are signed in, you can tap/click "Apply Online" to begin the process.USAJOBS will ask you to select a resume to submit. We recommend that you submit a USAJOBS Resume Builder formatted resume so that you know you're submitting all the information we will need. You may also submit a resume in the format of your choice. For tips on what to include in your resume, see the USAJOBS site.USAJOBS will then allow you to include documentation from your USAJOBS Saved Documents area. You may also attach additional supporting documents during this stage, or you may wait until you reach Application Manager.You will then be required to respond to certify your application materials and you'll be given the chance to elect to provide demographic information (if you have completed this part of your USAJOBS profile).Finally, you will be transferred to FDA's Application Manager (USA Staffing) system to complete the occupational questionnaire and finalize your application for submission. Follow the on-screen instructions provided and respond to ALL questions presented to you. You will be allowed to finalize and submit additional documents one last time. You will review your application and make final submission. You will then be returned back to USAJOBS.Instructions for reviewing or editing your application:If you need to make a change to your application, or if you just want to know your application status, you will need to be logged in to your USAJOBS account. Tap/click on your name in the top-right corner, then select "Applications".You will see a list of the most recent applications you have submitted. Tap/click on the one you wish to review or edit. The item will expand and provide your current status, along with additional information about that application. If you wish to change something then tap/click the "Update Application" button.You will be taken through the same steps you did when you initially applied. You can make changes to add or remove supporting documents before being transferred over to FDA's Application Manager system where you can continue making changes to your responses to the occupational questionnaire. Step through the process as you did the first time, taking care to make the changes you need, and submitting in the final step.You are encouraged to apply online. Applying online will allow you to review and track the status of your application. 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 Customer HelpDesk at (888) 478-4340; TTY/TDD: (800) 877-8339; or by email . (If you request by e-mail, please replace the blank space in the body with the Vacancy Identification Number, VIN, which is:10178298.) Decisions on granting reasonable accommodation will be made on a case-by-case basis.Agency contact informationFDA Applicant Help Desk FDA Applicant Help Desk PhoneEmailAddress FDA Office of Operations 10903 New Hampshire Ave Silver Spring, MD US Next steps 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 strive to make selections within 45 days of the closing date of this announcement (06/30/2018).You will receive application status updates via email and via USAJOBS as the process unfolds. Fair & Transparent Fair & Transparent The Federal hiring process is setup to be fair and transparent. Please read the following guidance. Equal Employment Opportunity Policy 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. Reasonable Accommodation Policy Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application and hiring process should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis. A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits. Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when: An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job.An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace.An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events. You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis. Learn more about or Legal and regulatory guidance
Supervisory Interdisciplinary Scientist
Duties DutiesSummaryThis position is located within the Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Biotechnology Products (OBP), in Silver Spring, MD.This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-18-MP-10173201KJ under merit promotion procedures. Please review that announcement to see if you are eligible for consideration under merit promotion procedures. Applicants must apply separately for each announcement in order to be considered under both options. Additional selections may be made within the same geographical area FDA-wide.ResponsibilitiesThe Supervisory Interdisciplinary Scientist (Review Chief) responsibilities include:Manage the operation, functions and activities of the program to support regulatory scientific review with scientific technological approaches and scientific computing tools that reduce barriers in regulatory review efficiency.Develop and make recommendation for the enhancement and improvement of the mission.Initiate and implements new policies, systems, procedures and organizational structures to support the mission of the division.Address and solve unusual, complex and often precedent setting problems associated with the regulatory science program segment.Identify and help resolve technical and scientific computing problems.Provide direction and supervision to subordinate program staff.Participate in policy discussions and decisions to ensure consistency or review practices across the Office of Biotechnology Products (OBP) divisions.Collaborate and communicate with other Review Chiefs and OBP Senior Managers to address novel regulatory issues.Travel RequiredNot required Supervisory status Yes Promotion Potential 15 Job family (Series)Similar jobs Requirements Requirements Conditions of EmploymentCitizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement.Selective Service Registration: All males born on, or after, 12/31/1959, must be registered with the Selective Service OR have an approved exemption.FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the problem.Security and Background Requirements: Appointment will require passing a background investigation. Not meeting this requirement may be grounds for personnel action. If hired, you may be subject to a background check at a later time.Certification of Accuracy: All information concerning qualification for employment is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection or appropriate disciplinary action.Direct Deposit: You will be required to have your federal salary payments electronically deposited into an account with a financial institution of your choice.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.Supervisory probationary period may be required. QualificationsIn order to qualify for Supervisory Interdisciplinary Scientist, 0401/0403/0405/1320, at GS - 15, you must meet the following:Biologist, GS- 401: Degree: biological science, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position; OR Combination of education and experience: Courses equivalent to a major, as shown in A above, plus appropriate experience or additional education.Microbiologist, GS- 403: Degree: microbiology, biology, chemist, or basic medical science that include 20 semester hours in microbiology or other subjects related to the study of microorganisms and 20 semester hours physical and mathematical science combing course work in organic chemistry or biochemistry, physics, and college algebra, or their equivalent; OR a combination of education and experience: Courses equivalent to a major in microbiology, biology, chemistry, or basic medical science that included courses as shown above, plus appropriate experience or additional education.Pharmacologist, GS- 405: Degree: biology, 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.Chemist, GS- 1320: Degree: physical science, life science , or engineering that included 30 semester hours in chemistry, supplemented by course work in mathematics through differential and integral calculus, and at least 6 semester hours of physics; OR combination of education and experience: Course work equivalent to a major shown above, including at least 30 semester hours in chemistry and 6 hours of physics.In addition to the above, applicants must meet the below specialized experience regimented. Have one year of specialized experience equivalent to at least the GS-14 in the Federal service include: Managing and directing a highly technical staff involved in the regulation of biotechnology product quality; Serving as principal advisor on all matters related to planning, developing and administering the assessment of biotechnology product quality and state-of-the-art technology; Utilizing expertise in cutting edge science and regulatory standards to make critical judgments on biotechnology products for human use; and Providing leadership on scientific and regulatory activities involved in the regulation of biotechnology quality. Education If you are claiming education as any part of your qualifications for this position, you must submit an official transcripts, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. 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 more information about this requirement, please visit the Additional informationADDITIONAL CONDITIONS OF EMPLOYMENT:If you are serving, or have served in the last 5 years (from 04/13/2018) 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. 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: NODrug Testing Requirement: NOLicense Requirement: NOImmunization Requirement: NOMobility Agreement Required: NOBargaining Unit Position: NO- 8888Veteran'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. .Selective Service Registration: Males born after December 31, 1959 must be registered or exempt from Selective Service. You can learn more by visiting the 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. Inter-agency and 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. .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. How You Will Be EvaluatedYou 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 04/13/2018), 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 or not 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 veteran's 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-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.Program ManagementLeadership/Supervisory SkillsOral CommunicationWritten CommunicationTo preview the application assessment questions, use the link below:Background checks and security clearanceSecurity clearance Required Documents Required DocumentsThe following documents are REQUIRED for this vacancy:ResumeTranscript"Required" indicates that the above documents are required to determine your 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 not qualified. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application.The following documents are ACCEPTED for this vacancy:Cover LetterDD-214VA LetterResumeSF-15Transcript"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.ADDITIONAL DOCUMENTATION REQUIREMENTS FOR APPLICANTS WHO WISH TO APPLY FOR SPECIAL APPOINTING AUTHORITIES:Veterans: (DD-214 Member #4 Copy, VA Letter, Standard Form (SF) 15 as applicable). Please note: 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.Persons with Disabilities: Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities may apply for appointment through the Schedule A hiring authority. 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.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 for more information. If you are relying on your education to meet qualification requirements: Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from . 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. Benefits Benefits 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. . 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 to Apply How to ApplyTo apply for positions with the Food & Drug Administration, you must have a USAJOBS account and be signed in to that account when you click "Apply Online". Additionally, you must provide a resume, 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, 04/13/2018. 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: . Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Help site at: . The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are unfamiliar with Application Manager, and you encounter any difficulty with the site, we recommend that you first consult the Applicant Help Site at: . 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 and 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. 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) 10173354 so that we may assist you faster.Agency contact informationFDA Applicant Help Desk FDA Applicant Help Desk PhoneEmailAddress FDA Center for Drug Evaluation and Research 10903 New Hampshire Ave Silver Spring, MD US Next steps 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 strive to make selections within 45 days of the closing date of this announcement (04/13/2018).You will receive application status updates via email and via USAJOBS as the process unfolds. Fair & Transparent Fair & Transparent The Federal hiring process is setup to be fair and transparent. Please read the following guidance. Equal Employment Opportunity Policy 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. Reasonable Accommodation Policy Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application and hiring process should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis. A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits. Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when: An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job.An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace.An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events. You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis. Learn more about or Legal and regulatory guidance
Supervisory Interdisciplinary Scientist
Duties DutiesSummaryThis position is located within the Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Biotechnology Products (OBP), in Silver Spring, MD.This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-18-MP-10173201KJ under merit promotion procedures. Please review that announcement to see if you are eligible for consideration under merit promotion procedures. Applicants must apply separately for each announcement in order to be considered under both options. Additional selections may be made within the same geographical area FDA-wide.ResponsibilitiesThe Supervisory Interdisciplinary Scientist (Review Chief) responsibilities include:Manage the operation, functions and activities of the program to support regulatory scientific review with scientific technological approaches and scientific computing tools that reduce barriers in regulatory review efficiency.Develop and make recommendation for the enhancement and improvement of the mission.Initiate and implements new policies, systems, procedures and organizational structures to support the mission of the division.Address and solve unusual, complex and often precedent setting problems associated with the regulatory science program segment.Identify and help resolve technical and scientific computing problems.Provide direction and supervision to subordinate program staff.Participate in policy discussions and decisions to ensure consistency or review practices across the Office of Biotechnology Products (OBP) divisions.Collaborate and communicate with other Review Chiefs and OBP Senior Managers to address novel regulatory issues.Travel RequiredNot required Supervisory status Yes Promotion Potential 15 Job family (Series)Similar jobs Requirements Requirements Conditions of EmploymentCitizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement.Selective Service Registration: All males born on, or after, 12/31/1959, must be registered with the Selective Service OR have an approved exemption.FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the problem.Security and Background Requirements: Appointment will require passing a background investigation. Not meeting this requirement may be grounds for personnel action. If hired, you may be subject to a background check at a later time.Certification of Accuracy: All information concerning qualification for employment is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection or appropriate disciplinary action.Direct Deposit: You will be required to have your federal salary payments electronically deposited into an account with a financial institution of your choice.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.Supervisory probationary period may be required. QualificationsIn order to qualify for Supervisory Interdisciplinary Scientist, 0401/0403/0405/1320, at GS - 15, you must meet the following:Biologist, GS- 401: Degree: biological science, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position; OR Combination of education and experience: Courses equivalent to a major, as shown in A above, plus appropriate experience or additional education.Microbiologist, GS- 403: Degree: microbiology, biology, chemist, or basic medical science that include 20 semester hours in microbiology or other subjects related to the study of microorganisms and 20 semester hours physical and mathematical science combing course work in organic chemistry or biochemistry, physics, and college algebra, or their equivalent; OR a combination of education and experience: Courses equivalent to a major in microbiology, biology, chemistry, or basic medical science that included courses as shown above, plus appropriate experience or additional education.Pharmacologist, GS- 405: Degree: biology, 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.Chemist, GS- 1320: Degree: physical science, life science , or engineering that included 30 semester hours in chemistry, supplemented by course work in mathematics through differential and integral calculus, and at least 6 semester hours of physics; OR combination of education and experience: Course work equivalent to a major shown above, including at least 30 semester hours in chemistry and 6 hours of physics.In addition to the above, applicants must meet the below specialized experience regimented. Have one year of specialized experience equivalent to at least the GS-14 in the Federal service include: Managing and directing a highly technical staff involved in the regulation of biotechnology product quality; Serving as principal advisor on all matters related to planning, developing and administering the assessment of biotechnology product quality and state-of-the-art technology; Utilizing expertise in cutting edge science and regulatory standards to make critical judgments on biotechnology products for human use; and Providing leadership on scientific and regulatory activities involved in the regulation of biotechnology quality. Education If you are claiming education as any part of your qualifications for this position, you must submit an official transcripts, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. 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 more information about this requirement, please visit the Additional informationADDITIONAL CONDITIONS OF EMPLOYMENT:If you are serving, or have served in the last 5 years (from 04/13/2018) 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. 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: NODrug Testing Requirement: NOLicense Requirement: NOImmunization Requirement: NOMobility Agreement Required: NOBargaining Unit Position: NO- 8888Veteran'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. .Selective Service Registration: Males born after December 31, 1959 must be registered or exempt from Selective Service. You can learn more by visiting the 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. Inter-agency and 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. .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. How You Will Be EvaluatedYou 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 04/13/2018), 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 or not 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 veteran's 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-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.Program ManagementLeadership/Supervisory SkillsOral CommunicationWritten CommunicationTo preview the application assessment questions, use the link below:Background checks and security clearanceSecurity clearance Required Documents Required DocumentsThe following documents are REQUIRED for this vacancy:ResumeTranscript"Required" indicates that the above documents are required to determine your 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 not qualified. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application.The following documents are ACCEPTED for this vacancy:Cover LetterDD-214VA LetterResumeSF-15Transcript"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.ADDITIONAL DOCUMENTATION REQUIREMENTS FOR APPLICANTS WHO WISH TO APPLY FOR SPECIAL APPOINTING AUTHORITIES:Veterans: (DD-214 Member #4 Copy, VA Letter, Standard Form (SF) 15 as applicable). Please note: 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.Persons with Disabilities: Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities may apply for appointment through the Schedule A hiring authority. 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.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 for more information. If you are relying on your education to meet qualification requirements: Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from . 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. Benefits Benefits 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. . 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 to Apply How to ApplyTo apply for positions with the Food & Drug Administration, you must have a USAJOBS account and be signed in to that account when you click "Apply Online". Additionally, you must provide a resume, 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, 04/13/2018. 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: . Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Help site at: . The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are unfamiliar with Application Manager, and you encounter any difficulty with the site, we recommend that you first consult the Applicant Help Site at: . 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 and 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. 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) 10173354 so that we may assist you faster.Agency contact informationFDA Applicant Help Desk FDA Applicant Help Desk PhoneEmailAddress FDA Center for Drug Evaluation and Research 10903 New Hampshire Ave Silver Spring, MD US Next steps 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 strive to make selections within 45 days of the closing date of this announcement (04/13/2018).You will receive application status updates via email and via USAJOBS as the process unfolds. Fair & Transparent Fair & Transparent The Federal hiring process is setup to be fair and transparent. Please read the following guidance. Equal Employment Opportunity Policy 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. Reasonable Accommodation Policy Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application and hiring process should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis. A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits. Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when: An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job.An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace.An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events. You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis. Learn more about or Legal and regulatory guidance
Technical Information Specialist
Duties DutiesSummaryThis position is located in the Center for Drug Evaluation Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Process and Facilities (OPF), Division of Microbiology Assessment (DMA), in Silver Spring, MD. This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-MP-18-10174246WH under merit promotion procedures. Please review that announcement to see if you are eligible for consideration under merit promotion procedures. Applicants must apply separately for each announcement in order to be considered under both options. Additional selections may be made within the same geographical area FDA-wide.ResponsibilitiesIdentify, evaluate and assess the relevance of materials acquired for inclusion in information resources.Conduct analyses on incoming drug distributions reports to identify precisely the companies involved and the related new drug applicant.Conduct research searches for documents to support legal positions to answer FOI requests and procedures special reports to assure a comprehensive response.Apply database management, word processing, graphics and electronic mail networks to coordinate office activities.Provide consultation and guidance on electronic information storage and retrieval systems, theories, and technologies related to the design, structure, and functionality of end-user scientific and technical data management systems.Respond to a variety of requests related to drug distribution.Write and edit memoranda, letters, and database entries appropriate to the requirement of the document or record.Travel RequiredNot required Supervisory status No Promotion Potential 13 Job family (Series) Requirements Requirements Conditions of EmploymentCitizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement.Selective Service Registration: All males born on, or after, 12/31/1959, must be registered with the Selective Service OR have an approved exemption.FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the problem.Security and Background Requirements: Appointment will require passing a background investigation. Not meeting this requirement may be grounds for personnel action. If hired, you may be subject to a background check at a later time.Certification of Accuracy: All information concerning qualification for employment is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection or appropriate disciplinary action.Direct Deposit: You will be required to have your federal salary payments electronically deposited into an account with a financial institution of your choice.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.A one year probationary period may be required. QualificationsIn order to qualify for Technical Information Specialist, 1412, at GS - 9/11, you must meet the following:Basic Requirements: Education: A full 4-year course of study that meets all the requirements for a bachelor's degree with major study in technical information (Transcript must be submitted);OR Experience: Four years of experience that provided a knowledge of the basic principles, theories, practices, techniques, and terminology of a discipline or subject-matter field; an understanding of the standard methods, procedures, and techniques of research and analysis in the subject-matter field; Such experience must have been equivalent to that which would have been gained through a 4-year college curriculum;OR a combination of education and experience as described above.In addition to meeting the Basic Requirement above, you must also have:GS-09 grade level: At least one year of specialized experience (equivalent to the GS-07 level in the Federal service) that included assisting in the collection of submission information; organizing information to be disseminated through reports and/or websites; operating automated information gathering and reporting systems to store and retrieve data and collecting technical information from electronic databases for preparation of reports and presentations. OR possess 2 full years of progressively higher level graduate education leading to a master's degree or equivalent graduate degree, e.g., LL.B. or J.D., in a field related to the position to be filled ;OR possess a combination of the education and experience required for this grade in which your percentage of specialized experience and education totals to 100%.GS-11 grade level: At least one year of specialized experience (equivalent to the GS-09 level in the Federal service) that included collecting and reviewing submission information for errors; organizing information to be disseminated through reports and websites; evaluating the accuracy of electronic data, conducting quality assessments of data; and performing data gathering, quantitative/statistical and qualitative analysis to develop reports. OR possess 3 full years of progressively higher level graduate education leading to a degree or equivalent doctoral degree (Ph.D., M.D., or equivalent) in a field related to the position to be filled; OR possess a combination of the education and experience required for this grade in which your percentage of specialized experience and education totals to 100%. Education If you are claiming education as any part of your qualifications for this position, you must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. 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 on Additional informationADDITIONAL CONDITIONS OF EMPLOYMENT:If you are serving, or have served in the last 5 years (from 04/09/2018) 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. 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: NODrug Testing Requirement: NOLicense Requirement: NOImmunization Requirement: NOMobility Agreement Required: NOBargaining Unit Position: YES/3591Veteran'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. .Selective Service Registration: Males born after December 31, 1959 must be registered or exempt from Selective Service. You can learn more by visiting the 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. Inter-agency and 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. . How You Will Be EvaluatedYou 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 04/09/2018), 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 or not 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 veteran's 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-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.Data Gathering and AnalysisProgram ManagementTechnical GuidanceWritten CommunicationTo preview the application assessment questions, use the link below:Background checks and security clearanceSecurity clearance Required Documents Required DocumentsThe following documents are ACCEPTED for this vacancy:Cover LetterDD-214OtherOther Veterans DocumentResumeSF-15SF-50Transcript"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.The following documents are REQUIRED for this vacancy:Resume"Required" indicates that the above documents are required to determine your 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 not qualified. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application.ADDITIONAL DOCUMENTATION REQUIREMENTS FOR APPLICANTS WHO WISH TO APPLY FOR SPECIAL APPOINTING AUTHORITIES:Veterans: (DD-214 Member #4 Copy, VA Letter, Standard Form (SF) 15 as applicable). Please note: 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.Persons with Disabilities: Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities may apply for appointment through the Schedule A hiring authority. 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.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 for more information. If you are relying on your education to meet qualification requirements: Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from . 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. Benefits Benefits 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. . 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 to Apply How to ApplyTo apply for positions with the Food & Drug Administration, you must have a USAJOBS account and be signed in to that account when you click "Apply Online". Additionally, you must provide a resume, 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, 04/09/2018. 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: . Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Help site at: . The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are unfamiliar with Application Manager, and you encounter any difficulty with the site, we recommend that you first consult the Applicant Help Site at: . 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 and 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. 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) 10169425 so that we may assist you faster.Agency contact informationFDA Applicant Help Desk FDA Applicant Help Desk PhoneEmailAddress FDA Center for Drug Evaluation and Research 10903 New Hampshire Ave Silver Spring, MD US Next steps 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 strive to make selections within 45 days of the closing date of this announcement (04/09/2018).You will receive application status updates via email and via USAJOBS as the process unfolds. Fair & Transparent Fair & Transparent The Federal hiring process is setup to be fair and transparent. Please read the following guidance. Equal Employment Opportunity Policy 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. Reasonable Accommodation Policy Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application and hiring process should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis. A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits. Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when: An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job.An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace.An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events. You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis. Learn more about or Legal and regulatory guidance
Technical Information Specialist
Duties DutiesSummaryThis position is located in the Center for Drug Evaluation Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Process and Facilities (OPF), Division of Microbiology Assessment (DMA), in Silver Spring, MD. This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-MP-18-10174246WH under merit promotion procedures. Please review that announcement to see if you are eligible for consideration under merit promotion procedures. Applicants must apply separately for each announcement in order to be considered under both options. Additional selections may be made within the same geographical area FDA-wide.ResponsibilitiesIdentify, evaluate and assess the relevance of materials acquired for inclusion in information resources.Conduct analyses on incoming drug distributions reports to identify precisely the companies involved and the related new drug applicant.Conduct research searches for documents to support legal positions to answer FOI requests and procedures special reports to assure a comprehensive response.Apply database management, word processing, graphics and electronic mail networks to coordinate office activities.Provide consultation and guidance on electronic information storage and retrieval systems, theories, and technologies related to the design, structure, and functionality of end-user scientific and technical data management systems.Respond to a variety of requests related to drug distribution.Write and edit memoranda, letters, and database entries appropriate to the requirement of the document or record.Travel RequiredNot required Supervisory status No Promotion Potential 13 Job family (Series) Requirements Requirements Conditions of EmploymentCitizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement.Selective Service Registration: All males born on, or after, 12/31/1959, must be registered with the Selective Service OR have an approved exemption.FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the problem.Security and Background Requirements: Appointment will require passing a background investigation. Not meeting this requirement may be grounds for personnel action. If hired, you may be subject to a background check at a later time.Certification of Accuracy: All information concerning qualification for employment is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection or appropriate disciplinary action.Direct Deposit: You will be required to have your federal salary payments electronically deposited into an account with a financial institution of your choice.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.A one year probationary period may be required. QualificationsIn order to qualify for Technical Information Specialist, 1412, at GS - 9/11, you must meet the following:Basic Requirements: Education: A full 4-year course of study that meets all the requirements for a bachelor's degree with major study in technical information (Transcript must be submitted);OR Experience: Four years of experience that provided a knowledge of the basic principles, theories, practices, techniques, and terminology of a discipline or subject-matter field; an understanding of the standard methods, procedures, and techniques of research and analysis in the subject-matter field; Such experience must have been equivalent to that which would have been gained through a 4-year college curriculum;OR a combination of education and experience as described above.In addition to meeting the Basic Requirement above, you must also have:GS-09 grade level: At least one year of specialized experience (equivalent to the GS-07 level in the Federal service) that included assisting in the collection of submission information; organizing information to be disseminated through reports and/or websites; operating automated information gathering and reporting systems to store and retrieve data and collecting technical information from electronic databases for preparation of reports and presentations. OR possess 2 full years of progressively higher level graduate education leading to a master's degree or equivalent graduate degree, e.g., LL.B. or J.D., in a field related to the position to be filled ;OR possess a combination of the education and experience required for this grade in which your percentage of specialized experience and education totals to 100%.GS-11 grade level: At least one year of specialized experience (equivalent to the GS-09 level in the Federal service) that included collecting and reviewing submission information for errors; organizing information to be disseminated through reports and websites; evaluating the accuracy of electronic data, conducting quality assessments of data; and performing data gathering, quantitative/statistical and qualitative analysis to develop reports. OR possess 3 full years of progressively higher level graduate education leading to a degree or equivalent doctoral degree (Ph.D., M.D., or equivalent) in a field related to the position to be filled; OR possess a combination of the education and experience required for this grade in which your percentage of specialized experience and education totals to 100%. Education If you are claiming education as any part of your qualifications for this position, you must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. 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 on Additional informationADDITIONAL CONDITIONS OF EMPLOYMENT:If you are serving, or have served in the last 5 years (from 04/09/2018) 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. 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: NODrug Testing Requirement: NOLicense Requirement: NOImmunization Requirement: NOMobility Agreement Required: NOBargaining Unit Position: YES/3591Veteran'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. .Selective Service Registration: Males born after December 31, 1959 must be registered or exempt from Selective Service. You can learn more by visiting the 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. Inter-agency and 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. . How You Will Be EvaluatedYou 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 04/09/2018), 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 or not 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 veteran's 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-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.Data Gathering and AnalysisProgram ManagementTechnical GuidanceWritten CommunicationTo preview the application assessment questions, use the link below:Background checks and security clearanceSecurity clearance Required Documents Required DocumentsThe following documents are ACCEPTED for this vacancy:Cover LetterDD-214OtherOther Veterans DocumentResumeSF-15SF-50Transcript"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.The following documents are REQUIRED for this vacancy:Resume"Required" indicates that the above documents are required to determine your 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 not qualified. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application.ADDITIONAL DOCUMENTATION REQUIREMENTS FOR APPLICANTS WHO WISH TO APPLY FOR SPECIAL APPOINTING AUTHORITIES:Veterans: (DD-214 Member #4 Copy, VA Letter, Standard Form (SF) 15 as applicable). Please note: 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.Persons with Disabilities: Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities may apply for appointment through the Schedule A hiring authority. 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.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 for more information. If you are relying on your education to meet qualification requirements: Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from . 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. Benefits Benefits 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. . 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 to Apply How to ApplyTo apply for positions with the Food & Drug Administration, you must have a USAJOBS account and be signed in to that account when you click "Apply Online". Additionally, you must provide a resume, 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, 04/09/2018. 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: . Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Help site at: . The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are unfamiliar with Application Manager, and you encounter any difficulty with the site, we recommend that you first consult the Applicant Help Site at: . 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 and 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. 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) 10169425 so that we may assist you faster.Agency contact informationFDA Applicant Help Desk FDA Applicant Help Desk PhoneEmailAddress FDA Center for Drug Evaluation and Research 10903 New Hampshire Ave Silver Spring, MD US Next steps 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 strive to make selections within 45 days of the closing date of this announcement (04/09/2018).You will receive application status updates via email and via USAJOBS as the process unfolds. Fair & Transparent Fair & Transparent The Federal hiring process is setup to be fair and transparent. Please read the following guidance. Equal Employment Opportunity Policy 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. Reasonable Accommodation Policy Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application and hiring process should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis. A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits. Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when: An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job.An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace.An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events. You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis. Learn more about or Legal and regulatory guidance
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