<b>Duties</b><br /><br /><b>Summary</b><br /><br />Serves as Health Scientist with the Center for Tobacco Products, Office of Science in matter pertaining to the Center's policy needs and activities relating to the regulation of tobacco products and it's effect on public health, particularly use and prevention.<br /> Learn more about this agency <br /><br /><b>Responsibilities</b><br /><br /><ul> <li>Establishes and implements strategy, objectives, and performance measures for assigned projects and prioritizes work.</li> <li>Compiles data to prepare presentations to support Agency recommendations on scientific issues pertaining to medicine and research.</li> <li>Provides scientific support in developing and/or updating regulatory or tobacco-related guidance and policy.</li> <li>Develops new concepts, methods, and strategies for obtaining and using data on the health risks associated with tobacco use.</li> <li>Develops research projects to fill gaps in knowledge related to regulatory decisions.</li> <li>Reviews documents submitted for regulatory action advises Center for Tobacco Products management on issues related to scientific subject matter; and provides verbal and written responses on all of the above.</li> <li>Reviews a wide range of tobacco product submissions from academic institutions and industry to determine the adequacy of the results from scientific studies (e.g., clinical studies, epidemiology studies, evaluation studies, and/or consumer studies).</li> <li>Demonstrate technical leadership by the following:</li> <li>1) Interpreting complex clinical and/or epidemiological aspects of new tobacco product applications.</li> <li>2) Reviewing study results and offering recommendations.</li> <li>3) Reviewing clinical and/or epidemiological data and, if needed, performing additional analysis of data submitted to tobacco product applications.</li> <li>4) Preparing a comprehensive synopsis of reviews of tobacco product submissions with recommendations for revisions/acceptance/rejections of sponsor proposals.</li> <li>5) Developing and implementing policies and recommendations for the conduct of scientific studies (e.g.) clinical epidemiological, and/or consumer-studies.</li> <li>6) Conducting literature searches to assure a good understanding of current practices in the areas of clinical-epidemiological, and/or consumer studies.</li> </ul> <br /><br /><b>Travel Required</b><br /><br />Occasional travel – You may be expected to travel 25% for this position.<br /><br />Supervisory status <br /> No <br /><br />Promotion Potential <br /> 13 <br /><br /></li> <b>Requirements</b><br /><br /><b>Conditions of Employment</b><br /><br /><ul> <li>Public Filer financial disclosure statement required, see the Additional Information section for details!</li> <li>Males born on, or after, December 31st 1959 must be registered with the Selective Service System or have an approved exemption. Visit www.SSS.gov for more info.</li> <li>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.</li> <li>Prohibited financial interest restrictions apply, see the Additional Information section for details!</li> <li>Veterans Preference DOES NOT APPLY to positions, such as this one, advertised under Title 42 (g) hiring regulations.</li> <li>You must be authorized to work in the United States.</li> <li>Qualified applicants will be considered and may or may not receive further notification regarding the status of their application.</li> <li>Telework is at the discretion of the supervisor.</li> <li>This is an Excepted Service position under Title 42. Applications will be accepted from qualified US Citizens or permanent residents. Must provide Proof of Residency. No previous Federal experience is required.</li> </ul> <br /><br /><b>Qualifications</b><br /><br /><strong>BASIC QUALIFICATION REQUIREMENTS:</strong> <br /> <strong>A. </strong>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.<br /> OR<br /> <strong>B</strong>. Appropriate combination of education as defined in item A above and specialized experience.<br /><br /><strong>In addition to meeting the Basic Requirements as stated above, applicants must also have either of the following experience:<br /><br />SPECIALIZED EXPERIENCE:<br /> GS-12: </strong><br /> Have one year of specialized experience, equivalent to the GS-11 grade level in the Federal service which includes providing input on various aspects of regulatory or public health programs in support of scientific review programs or activities and assisting with the overall integrity and accuracy of the Office's regulatory and scientific information.<br /><br /><strong>GS-13: </strong><br /> Have one year of specialized experience, equivalent to the GS-12 grade level in the Federal service which includes participating in the development of new methods, and strategies for obtaining and using data to assess or project the evaluation and/or impact of regulations and new policies (e.g. public health programs); and providing advice and assistance to scientists and officials participating in the areas of tobacco and/or regulatory science.<br /><br /><b>NOTE:</b> It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date. To verify your application is complete, log into your USAJOBS account, https: my.usajobs.gov/Account/Login , select the <b>Application Status </b>link and then select the <strong>More</strong><b>Information </b>link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Be sure that any uploaded documents you provide in your application are free of document security or compression which might render the document unreadable by our system.<br /><br /><strong>IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume.</strong> <br /><br /><b>Education</b><br /><br /><strong>Education:</strong> <br /> Minimum education required for Title 42g Staff Fellows: <br /><br />For Title 42g Staff Fellows the minimum quals requires: Doctoral-level degree from an accredited institution of higher learning, including: Ph.D., M.D., D.V.M., D.D.S., D.M.D., Sc.D., or other research doctoral-degree widely recognized in U.S. academe as equivalent to a Ph.D.<br /><br /><strong>Foreign Education:</strong> 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. <strong> For further information, visit the U.S. Department of Education website for Foreign Education Evaluation . </strong><br /><br /><strong>SUBMITTING YOUR TRANSCRIPTS: </strong> Positions which are scientific or technical in nature often have very specific educational requirements. A transcript is required to verify educational achievement. Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.<br /> <strong> Electronic Transcript Caution :</strong> If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.<br /><br /><strong>See the Application Manager Documentation for tips on submitting your paper-based documents.</strong> <br /><br /><b>Additional information</b><br /><br /><strong>Additional Conditions of Employment:</strong> <li><strong>Security and Background Requirements:</strong> This position requires a <strong>Secret </strong> Security Clearance . If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication of a Secret Clearance. Failure to successfully meet these requirements may be grounds for appropriate personnel action. Applicants are also advised that all information concerning qualification is subject to investigation. False representation may be grounds for non-selection and/or appropriate disciplinary action. Failure to obtain and maintain the required level of clearance may result in the withdrawal of a position offer or removal.</li> <li><strong>Political Appointees</strong>: If you are serving, or have served in the last 5 years (from 01/19/2018) 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. See the OPM page Political Appointees FAQ for more. </li> <li><strong>E-Verify: </strong>The U.S. Department of Health and Human Services is an E-Verify Participant. If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system.</li> <li><strong>Financial disclosure statement may be required.</strong> FDA inspires public confidence by maintaining high ethical principles, and all Federal Government employees are subject to the conflict of interest statutes and regulations, including the Standards of Ethical Conduct, that govern activities with outside organizations and reporting financial holdings. Certain positions within the FDA are subject to strict restrictions on financial holdings (FDA regulated financial holdings). The Ethics in Government Act, PL 95-521 also requires the applicant selected for this position to submit a Public Financial Disclosure Report, OGE-278, prior to assuming this position, annually, and upon termination of employment. To determine how this position is affected, applicants are advised to seek additional information during the interview process from the Ethics and Integrity Staff, Division Management Programs at (301) 796-8435 prior to accepting such a position.</li> <li><strong>Relocation and travel expense reimbursement:</strong> No</li> <li><strong>Financial disclosure: </strong>Yes</li> <li><strong>Bargaining United status:</strong> Yes; 3591</li> <br /><br /><b>How You Will Be Evaluated</b><br /><br />You will be evaluated for this job based on how well you meet the qualifications above.<br /><br />Once the job opportunity announcement closes (at 11:59 pm ET on 07/05/2019, a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for Federal employment, and then whether or not you are qualified for this particular position. See the USAJOBS help article " What is the difference between eligibility and qualifications? " for more… <br /><br />Qualification determinations will be based on the information provided in your application and the requirements of the position. Please follow all instructions carefully. Errors or omissions may affect your eligibility.<br /><br />To preview the assessment questionnaire, click this link: https: apply.usastaffing.gov/ViewQuestionnaire/10528838 <br /><br /><b>Background checks and security clearance</b><br /><br />Security clearance <br /> Other <br /><br />Drug test required <br /> No <br /><br />Position sensitivity and risk <br /> Noncritical-Sensitive (NCS)/Moderate Risk <br /><br />Trust determination process <br /> Suitability/Fitness <br /><br /></li> <b>Required Documents</b><br /><br /><strong>The following documents are REQUIRED :</strong><br /> <ul><li>Resume</li><li>Transcript</li></ul><br /> "Required" means that you must submit these documents in order for your application to be considered complete. If you fail to provide one of these documents, your application may not be considered.<br /><br /><strong>The following documents are ACCEPTED :</strong><br /> <ul><li>Cover Letter</li><li>DD-214/ Statement of Service</li><li>Disability Letter (Schedule A)</li><li>Disability Letter (VA)</li><li>License</li><li>Other (1)</li><li>PCS Orders</li><li>Performance Appraisal</li><li>Professional Certification</li><li>Resume</li><li>Separation Notice (RIF)</li><li>SF-15</li><li>SF-50/ Notification of Personnel Action</li><li>Transcript</li></ul><br /> "Accepted" means that you may optionally include the documents listed above in your application, if applicable to you. These documents are optional because they are not applicable to all applicants or are not used to determine your qualifications.<br /><br />If you have questions about the documentation requirements, please reference the following support articles: <ul> <li> How to understand the Required Documents for a job announcement (USAJOBS) </li> <li> What types of documents might I need to submit? (USAJOBS) </li> <li> Submitting documents with your application (Application Manager Help Site) </li> </ul> You may also contact the FDA Applicant Help Desk and reference VIN# 10528838. The help desk contact info is listed on this announcement. <br /><br /><b>If you are relying on your education to meet qualification requirements:</b><br /><br />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 schools accredited by accrediting institutions recognized by the U.S. Department of Education . <br /><br />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.

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