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Chemist
Duties DutiesSummaryPositions are located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA) in one of the following locations: College Park, MD, Laurel,MD, Rockville, MD and Silver Spring, MD This announcement will be used to fill varies positions. Positions may or may not have promotion potential. Additional selections may be made within the same geographical area FDA-wide.ResponsibilitiesExpert in the analysis, investigation, and characterization of the chemical composition and physical properties of: food components, drugs, antibiotics, agricultural chemicals, immunogenic agents, biological products, and/or environmental agents, hazardous and toxic substances.Plans, coordinates, and conducts complex research to investigate, analyze, and interpret the biochemical, biophysical, toxicological, and/or pharmacological composition, molecular structure, and chemical reaction of substances in natural and manmade environments.Develops and modifies analytical methods or research projects to study the composition, molecular structure, chemical properties, and chemical reactions of substances in natural and manmade environments and assesses their biological and toxicological effects.Determines the approach, methods, and procedures to use in order to obtain the information requested, taking into consideration the requirements established by Agency regulation and Federal law.Conducts scientific reviews of biochemical, environmental, toxicological and physiological data for unique scientific or regulatory issues involving the chemical properties of substances and evaluates the results to determine their scientific significance and application.Adapts and modifies currently used methods and procedures to improve them or extend their application to other substances or situations. Includes devising changes, performing the modified method, interpreting and evaluation the data, and wiring reports describing the modified method.Provides scientific advice to program staff and less experienced scientist on the precedents, analytical methods and instrumentation related to the particular scientific discipline of the position.Writes comprehensive, authoritative statistical and analytical reports from scientific investigations studies and projects.Identifies the sample or reports; show the methods and procedures used, any modifications with validations data, the results and their interpretation, and where the sample appears to be in violation of any agency regulation.Travel RequiredNot required Supervisory status No Promotion Potential 13 Job family (Series)Similar jobs Requirements Requirements Conditions of EmploymentCitizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.Selective Service Registration: All males born on, or after, 12/31/1959, must be registered with the Selective Service OR have an approved exemption. VIsit SSS.gov for more info.FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. You must continue to meet all requirements through the hiring process.Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice. Qualifications To qualify for the Chemist, GS-1320-13, you must meet the following:Basic Requirement: Degree: physical sciences, life sciences, 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 as shown in A above, including at least 30 semester hours in chemistry, supplemented by mathematics through differential and integral calculus, and at least 6 semester hours of physics, plus appropriate experience or additional education.Minimum Requirements In addition to the meeting the basic requirement, you must have one (1) year of specialized experience equivalent to at least the GS-12 grade level in the Federal service, to include industry or related experience in research and development, formulation, analytical methodology, and or manufacturing evaluating technical data reports on scientific results using modern analytical instrumentation including commercial statistical and data management software package to compile and process experimental data, and perform statistical analysis of data as assigned; regulatory method development and/or contract laboratory experience; and writes comprehensive, authoritative statistical and analytical reports from scientific investigations studies and projects.Note: To be considered for a Chemist position you must submit with your application an unofficial transcript(s) from an accredited college or university demonstrating you meet the education requirements listed above. See "Education" for information regarding Foreign Education. Positions are located in throughout the following FDA Centers: 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. Office of Regulatory Affairs (ORA) - Inspects regulated products and manufacturers, conducts sample analysis of regulated products and reviews imported products offered for entry into the United States. Center for Veterinary Medicine (CVM) - Reviews animal drug applications for safety and effectiveness, monitors animal drugs, animal foods, and devices on the market, reviews food additives for safety and utility, and conducts research that helps FDA ensure the safety of animal drugs, food for animals, and food products made from animals. CVM fosters human and animal health by approving safe and effective products for animals and by enforcing applicable provisions of the Federal Food, Drug, and Cosmetic Act and other authorities. These include animals, from which human foods are derived, as well as pet (or companion) animals. Center for Tobacco Products (CTP) - Set performance standards, review pre-market applications for new and modified risk tobacco products requiring new warning labels, and establishing and enforcing advertising and promotion restrictions.Listed below are desired experience for the following centers:CFSAN: Serve as regulatory (review) chemist in support of testing activities and other scientific investigations related to cosmetic products and ingredients. Determine what information or methods need to be developed to complete the various testing phases of the project. Maintain expert state-of-the-art knowledge of the particular area of research throughout the life of the project, reviewing available literature on new methods and techniques for potential application. Provide expertise for the development and selection of new methods for scientific investigation. Analyze research findings appropriate for guidance development, publication, and future reference by others. Collaborate with external stakeholders, including international regulatory health authorities and international industry organizations on issues related to cosmetic safety assessment.CVM: Evaluate the identity, strength, quality, and purity of drug substances of new animal drug products. Evaluate acceptability of changes to bulk drug synthesis, formulation and manufacturing process of animal drug products. Determine whether animal drug products have adequate controls to prevent microbiological contamination. Conduct technical review of feed data to determine identity and acceptability of substances intended for use in animal feed. Determine if manufacturing processes and analytical controls are adequate to produce a consistent food ingredient with specified purity, potency, quality and strength. Analyze feed substances to determine the levels of contamination and ensure compliance with the Code of Federal Regulations.CTP: Responsible for identifying, defining, and selecting specific problems for review, study and determining investigations and approaches to the problem area. Formulate hypotheses and develop and carry out the review of chemical studies, coping with novel, difficult, and unexpected problems. Perform key role in resolving issues that significantly affect scientific programs. Communicate scientifically, technical or complex concepts in writing. Communicate findings, interpretations and proposals orally.ORA: perform method development and regulatory chemical analysis in the Atlanta Center for Tobacco Analysis (ACTA). The incumbent will operate and maintain GC/MS equipment (LC/MS knowledge and tobacco experience will be considered as a bonus). A background in regulatory method development and/or contract laboratory experience is also desirable to demonstrate the ability to process a significant number of samples in relatively short time frames.CDER: Quality assessment for NDAs and ANDAs specifically focusing on the assessments of drug substance, product composition, product/process development, manufacturing process, reference standards, drug product controls, container closure, stability, and related regulations/policies. Evaluate identification and characterization of drug substance's physical, chemical, biological and mechanical properties and their impact on the drug product; Perform manufacturing processes and facilities used by foreign and domestic manufacturers of drug substances and/or products; Apply mastery of chemistry principles, practices and procedures including Process Analytical Technology to determine the adequacy of testing for raw materials and intermediates, the control of manufacturing processes, and the testing of the finished dosage forms; Participate in the facility inspections related to the evaluation of manufacturing processes and controls and in support of pre-approval and cGMP inspections. EducationForeign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For more information about this requirement, please visit the .Additional informationADDITIONAL CONDITIONS OF EMPLOYMENT:If 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. 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.Bargaining Unit Position: YesVeteran's Preference: If you plan to apply for any time of Veterans Preference, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. See for more.Selective Service Registration: Males born after December 31, 1959 must be registered or exempt from Selective Service. You can learn more by visiting the site.Schedule A: If you plan to apply under Schedule A based on a disability, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. See for more.Career Transition Assistance Programs: If you are a displaced Federal employee and plan to apply under CTAP or ICTAP, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. See for more.Financial disclosure statement, OGE-450, may be required: Please be advised that this position may 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 Eastern Time on 06/30/2018), a of your and will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your for Federal employment, and then whether you are 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: . 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 points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 30 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You need not respond to the KSA's directly, but your resume should contain sufficient information to demonstrate possession of the Competencies.ChemistryResearchTechnicalWritingTo preview the application assessment questions, click 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 necessary to determine your eligibility and/or qualification for this vacancy. These documents are collected from ALL applicants and failing to provide any of these documents may result in your application being deemed incomplete or ineligible. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application. If you need instructions or assistance with submitting documentation, please see the page for more information.RESUME REQUIREMENTS: The Federal Government has very specific requirements for the information that you must include in your resume. A resume for a Federal job will be much longer and more detailed than the type of resume you may be familiar with from the private sector, especially if you're accustomed to submitting in CV (curriculum vitae) format. If you have not written a Federal resume before, you may want to watch this video on the , or read through a helpful on the to learn what details you should, and should not, include in your resume. At a minimum, you should include: start and end dates for each position (including month and year), number of hours per week worked, level of experience and duties performed, employer name and address, supervisor name and contact, and salary (or grade and step), for each position listed in your work history.The following documents are ACCEPTED for this vacancy:Cover LetterDD-214ResumeSF-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. If you are unsure what documents might apply to you, please review the USAJOBS FAQ article: "" or contact the FDA Applicant Help Desk.ADDITIONAL DOCUMENTATION REQUIREMENTS FOR APPLICANTS WHO WISH TO APPLY FOR SPECIAL APPOINTING AUTHORITIES:Veterans: , including DD-214 Member #4 Copy, VA Letter, Standard Form (SF)-15, vary based on what preference you claim. If you are a veteran who has not yet been discharged, you may provide a statement of intent to discharge from your agency to receive Veterans Preference under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011. Learn more about Veterans Preference and documentation requirements on the USAJOBS Help Site for .Individuals with Disabilities: Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities may apply for appointment through the Schedule A hiring authority. Certified verification of a disability from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required. You can learn more about this appointment type on the USAJOBS Help Center page for .Displaced Federal employees who qualify for CTAP/ICTAP: If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. Please see the USAJOBS Help Site page for 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 account and be signed in to that account before you click the "Apply Online" button. See the USAJOBS Help Article "" for more on this process. Additionally, you must provide a resume and any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement, 06/30/2018. 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: . FDA's Applicant Help Desk is not able to support USAJOBS-related issues.The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are not familiar with Application Manager or you encounter any difficulty with the site, we recommend that you visit the Applicant HELP Site at: . 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 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 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) 10240812 so that we may assist you faster.Agency contact informationFDA Applicant Help Desk FDA Applicant Help Desk PhoneEmailAddress Office of Operations 10903 New Hampshire Ave Silver Spring, MD US Next steps Once your application is received, you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We strive to make selections within 45 days of the closing date of this announcement (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 process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants 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
Chemist
Duties DutiesSummaryPositions are located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA) in one of the following locations: College Park, MD, Laurel,MD, Rockville, MD and Silver Spring, MD This announcement will be used to fill varies positions. Positions may or may not have promotion potential. Additional selections may be made within the same geographical area FDA-wide.ResponsibilitiesExpert in the analysis, investigation, and characterization of the chemical composition and physical properties of: food components, drugs, antibiotics, agricultural chemicals, immunogenic agents, biological products, and/or environmental agents, hazardous and toxic substances.Plans, coordinates, and conducts complex research to investigate, analyze, and interpret the biochemical, biophysical, toxicological, and/or pharmacological composition, molecular structure, and chemical reaction of substances in natural and manmade environments.Develops and modifies analytical methods or research projects to study the composition, molecular structure, chemical properties, and chemical reactions of substances in natural and manmade environments and assesses their biological and toxicological effects.Determines the approach, methods, and procedures to use in order to obtain the information requested, taking into consideration the requirements established by Agency regulation and Federal law.Conducts scientific reviews of biochemical, environmental, toxicological and physiological data for unique scientific or regulatory issues involving the chemical properties of substances and evaluates the results to determine their scientific significance and application.Adapts and modifies currently used methods and procedures to improve them or extend their application to other substances or situations. Includes devising changes, performing the modified method, interpreting and evaluation the data, and wiring reports describing the modified method.Provides scientific advice to program staff and less experienced scientist on the precedents, analytical methods and instrumentation related to the particular scientific discipline of the position.Writes comprehensive, authoritative statistical and analytical reports from scientific investigations studies and projects.Identifies the sample or reports; show the methods and procedures used, any modifications with validations data, the results and their interpretation, and where the sample appears to be in violation of any agency regulation.Travel RequiredNot required Supervisory status No Promotion Potential 13 Job family (Series)Similar jobs Requirements Requirements Conditions of EmploymentCitizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.Selective Service Registration: All males born on, or after, 12/31/1959, must be registered with the Selective Service OR have an approved exemption. VIsit SSS.gov for more info.FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. You must continue to meet all requirements through the hiring process.Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice. Qualifications To qualify for the Chemist, GS-1320-13, you must meet the following:Basic Requirement: Degree: physical sciences, life sciences, 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 as shown in A above, including at least 30 semester hours in chemistry, supplemented by mathematics through differential and integral calculus, and at least 6 semester hours of physics, plus appropriate experience or additional education.Minimum Requirements In addition to the meeting the basic requirement, you must have one (1) year of specialized experience equivalent to at least the GS-12 grade level in the Federal service, to include industry or related experience in research and development, formulation, analytical methodology, and or manufacturing evaluating technical data reports on scientific results using modern analytical instrumentation including commercial statistical and data management software package to compile and process experimental data, and perform statistical analysis of data as assigned; regulatory method development and/or contract laboratory experience; and writes comprehensive, authoritative statistical and analytical reports from scientific investigations studies and projects.Note: To be considered for a Chemist position you must submit with your application an unofficial transcript(s) from an accredited college or university demonstrating you meet the education requirements listed above. See "Education" for information regarding Foreign Education. Positions are located in throughout the following FDA Centers: 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. Office of Regulatory Affairs (ORA) - Inspects regulated products and manufacturers, conducts sample analysis of regulated products and reviews imported products offered for entry into the United States. Center for Veterinary Medicine (CVM) - Reviews animal drug applications for safety and effectiveness, monitors animal drugs, animal foods, and devices on the market, reviews food additives for safety and utility, and conducts research that helps FDA ensure the safety of animal drugs, food for animals, and food products made from animals. CVM fosters human and animal health by approving safe and effective products for animals and by enforcing applicable provisions of the Federal Food, Drug, and Cosmetic Act and other authorities. These include animals, from which human foods are derived, as well as pet (or companion) animals. Center for Tobacco Products (CTP) - Set performance standards, review pre-market applications for new and modified risk tobacco products requiring new warning labels, and establishing and enforcing advertising and promotion restrictions.Listed below are desired experience for the following centers:CFSAN: Serve as regulatory (review) chemist in support of testing activities and other scientific investigations related to cosmetic products and ingredients. Determine what information or methods need to be developed to complete the various testing phases of the project. Maintain expert state-of-the-art knowledge of the particular area of research throughout the life of the project, reviewing available literature on new methods and techniques for potential application. Provide expertise for the development and selection of new methods for scientific investigation. Analyze research findings appropriate for guidance development, publication, and future reference by others. Collaborate with external stakeholders, including international regulatory health authorities and international industry organizations on issues related to cosmetic safety assessment.CVM: Evaluate the identity, strength, quality, and purity of drug substances of new animal drug products. Evaluate acceptability of changes to bulk drug synthesis, formulation and manufacturing process of animal drug products. Determine whether animal drug products have adequate controls to prevent microbiological contamination. Conduct technical review of feed data to determine identity and acceptability of substances intended for use in animal feed. Determine if manufacturing processes and analytical controls are adequate to produce a consistent food ingredient with specified purity, potency, quality and strength. Analyze feed substances to determine the levels of contamination and ensure compliance with the Code of Federal Regulations.CTP: Responsible for identifying, defining, and selecting specific problems for review, study and determining investigations and approaches to the problem area. Formulate hypotheses and develop and carry out the review of chemical studies, coping with novel, difficult, and unexpected problems. Perform key role in resolving issues that significantly affect scientific programs. Communicate scientifically, technical or complex concepts in writing. Communicate findings, interpretations and proposals orally.ORA: perform method development and regulatory chemical analysis in the Atlanta Center for Tobacco Analysis (ACTA). The incumbent will operate and maintain GC/MS equipment (LC/MS knowledge and tobacco experience will be considered as a bonus). A background in regulatory method development and/or contract laboratory experience is also desirable to demonstrate the ability to process a significant number of samples in relatively short time frames.CDER: Quality assessment for NDAs and ANDAs specifically focusing on the assessments of drug substance, product composition, product/process development, manufacturing process, reference standards, drug product controls, container closure, stability, and related regulations/policies. Evaluate identification and characterization of drug substance's physical, chemical, biological and mechanical properties and their impact on the drug product; Perform manufacturing processes and facilities used by foreign and domestic manufacturers of drug substances and/or products; Apply mastery of chemistry principles, practices and procedures including Process Analytical Technology to determine the adequacy of testing for raw materials and intermediates, the control of manufacturing processes, and the testing of the finished dosage forms; Participate in the facility inspections related to the evaluation of manufacturing processes and controls and in support of pre-approval and cGMP inspections. EducationForeign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For more information about this requirement, please visit the .Additional informationADDITIONAL CONDITIONS OF EMPLOYMENT:If 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. 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.Bargaining Unit Position: YesVeteran's Preference: If you plan to apply for any time of Veterans Preference, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. See for more.Selective Service Registration: Males born after December 31, 1959 must be registered or exempt from Selective Service. You can learn more by visiting the site.Schedule A: If you plan to apply under Schedule A based on a disability, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. See for more.Career Transition Assistance Programs: If you are a displaced Federal employee and plan to apply under CTAP or ICTAP, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. See for more.Financial disclosure statement, OGE-450, may be required: Please be advised that this position may 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 Eastern Time on 06/30/2018), a of your and will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your for Federal employment, and then whether you are 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: . 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 points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 30 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You need not respond to the KSA's directly, but your resume should contain sufficient information to demonstrate possession of the Competencies.ChemistryResearchTechnicalWritingTo preview the application assessment questions, click 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 necessary to determine your eligibility and/or qualification for this vacancy. These documents are collected from ALL applicants and failing to provide any of these documents may result in your application being deemed incomplete or ineligible. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application. If you need instructions or assistance with submitting documentation, please see the page for more information.RESUME REQUIREMENTS: The Federal Government has very specific requirements for the information that you must include in your resume. A resume for a Federal job will be much longer and more detailed than the type of resume you may be familiar with from the private sector, especially if you're accustomed to submitting in CV (curriculum vitae) format. If you have not written a Federal resume before, you may want to watch this video on the , or read through a helpful on the to learn what details you should, and should not, include in your resume. At a minimum, you should include: start and end dates for each position (including month and year), number of hours per week worked, level of experience and duties performed, employer name and address, supervisor name and contact, and salary (or grade and step), for each position listed in your work history.The following documents are ACCEPTED for this vacancy:Cover LetterDD-214ResumeSF-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. If you are unsure what documents might apply to you, please review the USAJOBS FAQ article: "" or contact the FDA Applicant Help Desk.ADDITIONAL DOCUMENTATION REQUIREMENTS FOR APPLICANTS WHO WISH TO APPLY FOR SPECIAL APPOINTING AUTHORITIES:Veterans: , including DD-214 Member #4 Copy, VA Letter, Standard Form (SF)-15, vary based on what preference you claim. If you are a veteran who has not yet been discharged, you may provide a statement of intent to discharge from your agency to receive Veterans Preference under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011. Learn more about Veterans Preference and documentation requirements on the USAJOBS Help Site for .Individuals with Disabilities: Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities may apply for appointment through the Schedule A hiring authority. Certified verification of a disability from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required. You can learn more about this appointment type on the USAJOBS Help Center page for .Displaced Federal employees who qualify for CTAP/ICTAP: If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. Please see the USAJOBS Help Site page for 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 account and be signed in to that account before you click the "Apply Online" button. See the USAJOBS Help Article "" for more on this process. Additionally, you must provide a resume and any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement, 06/30/2018. 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: . FDA's Applicant Help Desk is not able to support USAJOBS-related issues.The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are not familiar with Application Manager or you encounter any difficulty with the site, we recommend that you visit the Applicant HELP Site at: . 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 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 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) 10240812 so that we may assist you faster.Agency contact informationFDA Applicant Help Desk FDA Applicant Help Desk PhoneEmailAddress Office of Operations 10903 New Hampshire Ave Silver Spring, MD US Next steps Once your application is received, you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We strive to make selections within 45 days of the closing date of this announcement (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 process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants 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
General Health Scientist
Duties DutiesSummaryThis position is located in the Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology, Immediate Office of the Director, located in Silver Spring, MD. Additional selections may be made within the same geographical area.ResponsibilitiesLead multidisciplinary workgroups to perform post-market surveillance of biologics.Present scientific reviews to the medical and scientific experts who serve as panel members of the Advisory committee.Serve as a recognized authority to identify and analyze post-surveillance issues and their impact on scientific operations.Design new studies and write protocols for post-market performance evaluation of biologics using large databases composed of claims and administrative data.Travel Required25% or less - You may be expected to travel for this position. 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 unless explicitly stated otherwise.Selective Service Registration: All males born on, or after, 12/31/1959, must be registered with the Selective Service OR have an approved exemption. VIsit SSS.gov for more info.FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. You must continue to meet all requirements through the hiring process.Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.One year probationary period may be required. QualificationsIn order to for General Health Scientist, GS-0601-13, you must meet the following: Have successfully completed Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education (external link) at the time the degree was obtained. AND In addition, you must have one (1) year of specialized experience at the next lower grade level, GS-12 in or related to General Health Science that provided the specific knowledge, skills, and abilities to perform successfully the duties of the position. Specialized experience include experience using real world data, relating to the evaluation of patient health status and the delivery of health care routinely collected from a variety of sources; writing protocols; performing safety post-market surveillance and performing risk and benefit assessment of biologic products. EducationForeign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For more information about this requirement, please visit the .Additional informationADDITIONAL CONDITIONS OF EMPLOYMENT:If you are serving, or have served in the last 5 years (from 07/03/2018) 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. See for more.Selective Service Registration: Males born after December 31, 1959 must be registered or exempt from Selective Service. You can learn more by visiting the site.Schedule A: If you plan to apply under Schedule A based on a disability, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. See for more.Career Transition Assistance Programs: If you are a displaced Federal employee and plan to apply under CTAP or ICTAP, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. See for more.Financial disclosure statement, OGE-450, required: Please be advised that this position will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers.. 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 Eastern Time on 07/03/2018), a of your and will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your for Federal employment, and then whether you are 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: . 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 points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 30 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You need not respond to the KSA's directly, but your resume should contain sufficient information to demonstrate possession of the Competencies.Scientific & Regulatory AdvisementTechnical CompetencyOral/Written CommunicationTo preview the application assessment questions, click 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 necessary to determine your eligibility and/or qualification for this vacancy. These documents are collected from ALL applicants and failing to provide any of these documents may result in your application being deemed incomplete or ineligible. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application. If you need instructions or assistance with submitting documentation, please see the page for more information.RESUME REQUIREMENTS: The Federal Government has very specific requirements for the information that you must include in your resume. A resume for a Federal job will be much longer and more detailed than the type of resume you may be familiar with from the private sector, especially if you're accustomed to submitting in CV (curriculum vitae) format. If you have not written a Federal resume before, you may want to watch this video on the , or read through a helpful on the to learn what details you should, and should not, include in your resume. At a minimum, you should include: start and end dates for each position (including month and year), number of hours per week worked, level of experience and duties performed, employer name and address, supervisor name and contact, and salary (or grade and step), for each position listed in your work history.The following documents are ACCEPTED for this vacancy:Cover LetterDD-214OtherVA LetterResumeSF-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. If you are unsure what documents might apply to you, please review the USAJOBS FAQ article: "" or contact the FDA Applicant Help Desk.ADDITIONAL DOCUMENTATION REQUIREMENTS FOR APPLICANTS WHO WISH TO APPLY FOR SPECIAL APPOINTING AUTHORITIES:Veterans: , including DD-214 Member #4 Copy, VA Letter, Standard Form (SF)-15, vary based on what preference you claim. If you are a veteran who has not yet been discharged, you may provide a statement of intent to discharge from your agency to receive Veterans Preference under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011. Learn more about Veterans Preference and documentation requirements on the USAJOBS Help Site for .Individuals with Disabilities: Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities may apply for appointment through the Schedule A hiring authority. Certified verification of a disability from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required. You can learn more about this appointment type on the USAJOBS Help Center page for .Displaced Federal employees who qualify for CTAP/ICTAP: If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. Please see the USAJOBS Help Site page for 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 account and be signed in to that account before you click the "Apply Online" button. See the USAJOBS Help Article "" for more on this process. Additionally, you must provide a resume and any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement, 07/03/2018. 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: . FDA's Applicant Help Desk is not able to support USAJOBS-related issues.The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are not familiar with Application Manager or you encounter any difficulty with the site, we recommend that you visit the Applicant HELP Site at: . 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 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 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) 10236183 so that we may assist you faster.Agency contact informationFDA Applicant Help Desk FDA Applicant Help Desk PhoneEmailAddress Center for Biologics Evaluation and Research 10903 New Hampshire Ave Silver Spring, MD US Next steps Once your application is received, you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We strive to make selections within 45 days of the closing date of this announcement (07/03/2018).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 process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants 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
General Health Scientist
Duties DutiesSummaryThis position is located in the Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology, Immediate Office of the Director, located in Silver Spring, MD. Additional selections may be made within the same geographical area.ResponsibilitiesLead multidisciplinary workgroups to perform post-market surveillance of biologics.Present scientific reviews to the medical and scientific experts who serve as panel members of the Advisory committee.Serve as a recognized authority to identify and analyze post-surveillance issues and their impact on scientific operations.Design new studies and write protocols for post-market performance evaluation of biologics using large databases composed of claims and administrative data.Travel Required25% or less - You may be expected to travel for this position. 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 unless explicitly stated otherwise.Selective Service Registration: All males born on, or after, 12/31/1959, must be registered with the Selective Service OR have an approved exemption. VIsit SSS.gov for more info.FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. You must continue to meet all requirements through the hiring process.Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.One year probationary period may be required. QualificationsIn order to for General Health Scientist, GS-0601-13, you must meet the following: Have successfully completed Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education (external link) at the time the degree was obtained. AND In addition, you must have one (1) year of specialized experience at the next lower grade level, GS-12 in or related to General Health Science that provided the specific knowledge, skills, and abilities to perform successfully the duties of the position. Specialized experience include experience using real world data, relating to the evaluation of patient health status and the delivery of health care routinely collected from a variety of sources; writing protocols; performing safety post-market surveillance and performing risk and benefit assessment of biologic products. EducationForeign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For more information about this requirement, please visit the .Additional informationADDITIONAL CONDITIONS OF EMPLOYMENT:If you are serving, or have served in the last 5 years (from 07/03/2018) 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. See for more.Selective Service Registration: Males born after December 31, 1959 must be registered or exempt from Selective Service. You can learn more by visiting the site.Schedule A: If you plan to apply under Schedule A based on a disability, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. See for more.Career Transition Assistance Programs: If you are a displaced Federal employee and plan to apply under CTAP or ICTAP, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. See for more.Financial disclosure statement, OGE-450, required: Please be advised that this position will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers.. 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 Eastern Time on 07/03/2018), a of your and will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your for Federal employment, and then whether you are 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: . 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 points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 30 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You need not respond to the KSA's directly, but your resume should contain sufficient information to demonstrate possession of the Competencies.Scientific & Regulatory AdvisementTechnical CompetencyOral/Written CommunicationTo preview the application assessment questions, click 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 necessary to determine your eligibility and/or qualification for this vacancy. These documents are collected from ALL applicants and failing to provide any of these documents may result in your application being deemed incomplete or ineligible. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application. If you need instructions or assistance with submitting documentation, please see the page for more information.RESUME REQUIREMENTS: The Federal Government has very specific requirements for the information that you must include in your resume. A resume for a Federal job will be much longer and more detailed than the type of resume you may be familiar with from the private sector, especially if you're accustomed to submitting in CV (curriculum vitae) format. If you have not written a Federal resume before, you may want to watch this video on the , or read through a helpful on the to learn what details you should, and should not, include in your resume. At a minimum, you should include: start and end dates for each position (including month and year), number of hours per week worked, level of experience and duties performed, employer name and address, supervisor name and contact, and salary (or grade and step), for each position listed in your work history.The following documents are ACCEPTED for this vacancy:Cover LetterDD-214OtherVA LetterResumeSF-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. If you are unsure what documents might apply to you, please review the USAJOBS FAQ article: "" or contact the FDA Applicant Help Desk.ADDITIONAL DOCUMENTATION REQUIREMENTS FOR APPLICANTS WHO WISH TO APPLY FOR SPECIAL APPOINTING AUTHORITIES:Veterans: , including DD-214 Member #4 Copy, VA Letter, Standard Form (SF)-15, vary based on what preference you claim. If you are a veteran who has not yet been discharged, you may provide a statement of intent to discharge from your agency to receive Veterans Preference under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011. Learn more about Veterans Preference and documentation requirements on the USAJOBS Help Site for .Individuals with Disabilities: Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities may apply for appointment through the Schedule A hiring authority. Certified verification of a disability from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required. You can learn more about this appointment type on the USAJOBS Help Center page for .Displaced Federal employees who qualify for CTAP/ICTAP: If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. Please see the USAJOBS Help Site page for 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 account and be signed in to that account before you click the "Apply Online" button. See the USAJOBS Help Article "" for more on this process. Additionally, you must provide a resume and any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement, 07/03/2018. 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: . FDA's Applicant Help Desk is not able to support USAJOBS-related issues.The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are not familiar with Application Manager or you encounter any difficulty with the site, we recommend that you visit the Applicant HELP Site at: . 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 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 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) 10236183 so that we may assist you faster.Agency contact informationFDA Applicant Help Desk FDA Applicant Help Desk PhoneEmailAddress Center for Biologics Evaluation and Research 10903 New Hampshire Ave Silver Spring, MD US Next steps Once your application is received, you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We strive to make selections within 45 days of the closing date of this announcement (07/03/2018).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 process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants 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
Management Analyst
Duties DutiesSummaryThis position is located in the U.S. Health and Human Services, Food and Drug Administration, Office of the Center Director (OCD), Silver Spring, Maryland.This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-18-MP-10239963 under merit promotion procedures. Additional selections may be made within the same geographical area FDA-wide.ResponsibilitiesResearch and draft summaries in support of Stakeholder Relations Officer (SRO) domestic and/or internal programs.Develop new or modified administrative program policies, goals or objectives in support of SRO's mission.Assist in monitoring international press to develop international resources.Assist with project management for ad hoc request and inquiries.Plan and conduct studies of Office programs, policies and strategies.Travel RequiredNot required Supervisory status No Promotion Potential 12 Job family (Series)Similar jobs Requirements Requirements Conditions of EmploymentCitizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.Selective Service Registration: All males born on, or after, 12/31/1959, must be registered with the Selective Service OR have an approved exemption. VIsit SSS.gov for more info.FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. You must continue to meet all requirements through the hiring process.Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice. QualificationsIn order to for Management Analyst, 0343, at GS - 9/11, you must meet the following: GS-9: You must have at least one (1) full year of specialized experience equivalent to the GS-7 grade level in the Federal or public and private sectors, assisting with monitoring international press and developing international resources and assisting with project management for ad hoc requests and inquiries. OR Have a master's or equivalent graduate degree OR Have 2 full years of progressively higher level graduate education leading to such a degree or LL.B. or J.D., if related OR Have a combination of education and experience that meets 100% of the qualification requirements for this position. GS:11 You must have at least one (1) full year of specialized experience equivalent to the GS-9 level in the Federal or public and private sectors developing new or modified administrative program policies, goals or objectives in support of a mission and assisting in analyzing and evaluating the effectiveness of a programs stakeholder relations. -OR- Have a Ph.D. or equivalent doctoral degree or 3 full years of progressively higher level graduate education leading to such a degree or LL.M., if related. -OR- Have a combination of education and experience that meets 100% of the qualification requirements for this position.EducationForeign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For more information about this requirement, please visit the .Additional informationADDITIONAL CONDITIONS OF EMPLOYMENT:If you are serving, or have served in the last 5 years (from 07/02/2018) 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. See for more.Selective Service Registration: Males born after December 31, 1959 must be registered or exempt from Selective Service. You can learn more by visiting the site.Schedule A: If you plan to apply under Schedule A based on a disability, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. See for more.Career Transition Assistance Programs: If you are a displaced Federal employee and plan to apply under CTAP or ICTAP, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. See for more. 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 Eastern Time on 07/02/2018), a of your and will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your for Federal employment, and then whether you are 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: . 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 points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 30 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You need not respond to the KSA's directly, but your resume should contain sufficient information to demonstrate possession of the Competencies.Technical Competency - Communication/Interpersonal SkillsPlanning and EvaluatingAdministrative and ManagementOral CommunicationWritingTo preview the application assessment questions, click the link below:Background checks and security clearanceSecurity clearance Required Documents Required DocumentsThe following documents are REQUIRED for this vacancy:Resume"Required" indicates that the above documents are necessary to determine your eligibility and/or qualification for this vacancy. These documents are collected from ALL applicants and failing to provide any of these documents may result in your application being deemed incomplete or ineligible. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application. If you need instructions or assistance with submitting documentation, please see the page for more information.RESUME REQUIREMENTS: The Federal Government has very specific requirements for the information that you must include in your resume. A resume for a Federal job will be much longer and more detailed than the type of resume you may be familiar with from the private sector, especially if you're accustomed to submitting in CV (curriculum vitae) format. If you have not written a Federal resume before, you may want to watch this video on the , or read through a helpful on the to learn what details you should, and should not, include in your resume. At a minimum, you should include: start and end dates for each position (including month and year), number of hours per week worked, level of experience and duties performed, employer name and address, supervisor name and contact, and salary (or grade and step), for each position listed in your work history.The following documents are ACCEPTED for this vacancy:DD-214Schedule A LetterVA LetterResumeTranscript"Accepted" means that you will have the opportunity to submit these documents, if they are applicable to you. Such documents include Veteran Preference or other special eligibility documentation, transcripts, or other optional documentation that helps us determine your eligibility. The above list of documents may not apply to all applicants. If you are unsure what documents might apply to you, please review the USAJOBS FAQ article: "" or contact the FDA Applicant Help Desk.ADDITIONAL DOCUMENTATION REQUIREMENTS FOR APPLICANTS WHO WISH TO APPLY FOR SPECIAL APPOINTING AUTHORITIES:Veterans: , including DD-214 Member #4 Copy, VA Letter, Standard Form (SF)-15, vary based on what preference you claim. If you are a veteran who has not yet been discharged, you may provide a statement of intent to discharge from your agency to receive Veterans Preference under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011. Learn more about Veterans Preference and documentation requirements on the USAJOBS Help Site for .Individuals with Disabilities: Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities may apply for appointment through the Schedule A hiring authority. Certified verification of a disability from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required. You can learn more about this appointment type on the USAJOBS Help Center page for .Displaced Federal employees who qualify for CTAP/ICTAP: If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. Please see the USAJOBS Help Site page for 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 account and be signed in to that account before you click the "Apply Online" button. See the USAJOBS Help Article "" for more on this process. Additionally, you must provide a resume and any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement, 07/02/2018. 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: . FDA's Applicant Help Desk is not able to support USAJOBS-related issues.The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are not familiar with Application Manager or you encounter any difficulty with the site, we recommend that you visit the Applicant HELP Site at: . 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 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 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) 10239962 so that we may assist you faster.Agency contact informationFDA Applicant Help Desk FDA Applicant Help Desk PhoneEmailAddress Center for Tobacco Products 10903 New Hampshire Ave Silver Spring, MD US Next steps Once your application is received, you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We strive to make selections within 45 days of the closing date of this announcement (07/02/2018).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 process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants 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
Management Analyst
Duties DutiesSummaryThis position is located in the U.S. Health and Human Services, Food and Drug Administration, Office of the Center Director (OCD), Silver Spring, Maryland.This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-18-MP-10239963 under merit promotion procedures. Additional selections may be made within the same geographical area FDA-wide.ResponsibilitiesResearch and draft summaries in support of Stakeholder Relations Officer (SRO) domestic and/or internal programs.Develop new or modified administrative program policies, goals or objectives in support of SRO's mission.Assist in monitoring international press to develop international resources.Assist with project management for ad hoc request and inquiries.Plan and conduct studies of Office programs, policies and strategies.Travel RequiredNot required Supervisory status No Promotion Potential 12 Job family (Series)Similar jobs Requirements Requirements Conditions of EmploymentCitizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.Selective Service Registration: All males born on, or after, 12/31/1959, must be registered with the Selective Service OR have an approved exemption. VIsit SSS.gov for more info.FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. You must continue to meet all requirements through the hiring process.Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice. QualificationsIn order to for Management Analyst, 0343, at GS - 9/11, you must meet the following: GS-9: You must have at least one (1) full year of specialized experience equivalent to the GS-7 grade level in the Federal or public and private sectors, assisting with monitoring international press and developing international resources and assisting with project management for ad hoc requests and inquiries. OR Have a master's or equivalent graduate degree OR Have 2 full years of progressively higher level graduate education leading to such a degree or LL.B. or J.D., if related OR Have a combination of education and experience that meets 100% of the qualification requirements for this position. GS:11 You must have at least one (1) full year of specialized experience equivalent to the GS-9 level in the Federal or public and private sectors developing new or modified administrative program policies, goals or objectives in support of a mission and assisting in analyzing and evaluating the effectiveness of a programs stakeholder relations. -OR- Have a Ph.D. or equivalent doctoral degree or 3 full years of progressively higher level graduate education leading to such a degree or LL.M., if related. -OR- Have a combination of education and experience that meets 100% of the qualification requirements for this position.EducationForeign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For more information about this requirement, please visit the .Additional informationADDITIONAL CONDITIONS OF EMPLOYMENT:If you are serving, or have served in the last 5 years (from 07/02/2018) 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. See for more.Selective Service Registration: Males born after December 31, 1959 must be registered or exempt from Selective Service. You can learn more by visiting the site.Schedule A: If you plan to apply under Schedule A based on a disability, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. See for more.Career Transition Assistance Programs: If you are a displaced Federal employee and plan to apply under CTAP or ICTAP, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. See for more. 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 Eastern Time on 07/02/2018), a of your and will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your for Federal employment, and then whether you are 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: . 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 points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 30 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You need not respond to the KSA's directly, but your resume should contain sufficient information to demonstrate possession of the Competencies.Technical Competency - Communication/Interpersonal SkillsPlanning and EvaluatingAdministrative and ManagementOral CommunicationWritingTo preview the application assessment questions, click the link below:Background checks and security clearanceSecurity clearance Required Documents Required DocumentsThe following documents are REQUIRED for this vacancy:Resume"Required" indicates that the above documents are necessary to determine your eligibility and/or qualification for this vacancy. These documents are collected from ALL applicants and failing to provide any of these documents may result in your application being deemed incomplete or ineligible. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application. If you need instructions or assistance with submitting documentation, please see the page for more information.RESUME REQUIREMENTS: The Federal Government has very specific requirements for the information that you must include in your resume. A resume for a Federal job will be much longer and more detailed than the type of resume you may be familiar with from the private sector, especially if you're accustomed to submitting in CV (curriculum vitae) format. If you have not written a Federal resume before, you may want to watch this video on the , or read through a helpful on the to learn what details you should, and should not, include in your resume. At a minimum, you should include: start and end dates for each position (including month and year), number of hours per week worked, level of experience and duties performed, employer name and address, supervisor name and contact, and salary (or grade and step), for each position listed in your work history.The following documents are ACCEPTED for this vacancy:DD-214Schedule A LetterVA LetterResumeTranscript"Accepted" means that you will have the opportunity to submit these documents, if they are applicable to you. Such documents include Veteran Preference or other special eligibility documentation, transcripts, or other optional documentation that helps us determine your eligibility. The above list of documents may not apply to all applicants. If you are unsure what documents might apply to you, please review the USAJOBS FAQ article: "" or contact the FDA Applicant Help Desk.ADDITIONAL DOCUMENTATION REQUIREMENTS FOR APPLICANTS WHO WISH TO APPLY FOR SPECIAL APPOINTING AUTHORITIES:Veterans: , including DD-214 Member #4 Copy, VA Letter, Standard Form (SF)-15, vary based on what preference you claim. If you are a veteran who has not yet been discharged, you may provide a statement of intent to discharge from your agency to receive Veterans Preference under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011. Learn more about Veterans Preference and documentation requirements on the USAJOBS Help Site for .Individuals with Disabilities: Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities may apply for appointment through the Schedule A hiring authority. Certified verification of a disability from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required. You can learn more about this appointment type on the USAJOBS Help Center page for .Displaced Federal employees who qualify for CTAP/ICTAP: If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. Please see the USAJOBS Help Site page for 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 account and be signed in to that account before you click the "Apply Online" button. See the USAJOBS Help Article "" for more on this process. Additionally, you must provide a resume and any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement, 07/02/2018. 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: . FDA's Applicant Help Desk is not able to support USAJOBS-related issues.The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are not familiar with Application Manager or you encounter any difficulty with the site, we recommend that you visit the Applicant HELP Site at: . 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 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 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) 10239962 so that we may assist you faster.Agency contact informationFDA Applicant Help Desk FDA Applicant Help Desk PhoneEmailAddress Center for Tobacco Products 10903 New Hampshire Ave Silver Spring, MD US Next steps Once your application is received, you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We strive to make selections within 45 days of the closing date of this announcement (07/02/2018).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 process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants 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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