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The Congressional Research Service (CRS), Domestic Social Policy (DSP) Division seeks an Analyst in Health Policy to provide expertise on biological products (e.g., biologics, biosimilars, vaccines, cellular and gene therapy), and federal policies and procedures on regulating their safety, effectiveness, licensure, and marketing.
Learn more about this agency11/15/2023 to 12/29/2023
$112,015 - $145,617 per year
GS 13
No
Yes—as determined by the agency policy.
Not required
No
Permanent - Position
Full-time - Flexitime. Compflex.
Excepted
15
No
No
VAR002614
760852900
The ideal candidate will have academic and professional skills/training in biological and biomedical sciences (e.g., biotechnology, cellular and molecular biology, molecular medicine, molecular genetics, immunology, pharmacology); knowledge of the regulation of biological products by the U.S. Food and Drug Administration (FDA), FDA user fee programs, the FDA budget, and related topics; and an ability to analyze federal policy issues and legislative proposals relating to the regulation of biological products. Given the breadth of federal policy on biological and other medical products and their regulation, analysts must be capable of working on a range of issues in a portfolio that will likely evolve over time.
Responsibilities
We expect this analyst to work primarily on issues related to biological products, including vaccines; biosimilars; human cells, tissues, or cellular or tissue-based products (HCT/Ps); cellular and gene therapies; regenerative medicine; and brand and generic animal drugs. The analyst will need to be familiar with federal regulatory policy for biological products; relevant FDA user fee programs (e.g., BsUFA, AGDUFA, ADUFA); the FDA budget for the regulation of drugs and biologics; the Center for Biologics Evaluation and Research (CBER); significant relevant legislative efforts (e.g., 21st Century Cures Act, user fee reauthorization); as well as relevant cross-cutting agency initiatives (e.g., clinical trial diversity, digital health tools, IT modernization, etc.). Areas of responsibility may also include the legislative history of the regulation of drugs, biologics and biosimilars, user fees, the development and delivery of drugs and biologics, and medical devices. Other topics may be included in the research portfolio for this analyst to address evolving congressional needs. Over time, the analyst is expected to develop the skills necessary to provide legislative analysis and consultation on issues related to biological products at increasingly sophisticated levels to congressional committees, Members, and staff.
Applicants should have substantive knowledge of biological products and experience conducting relevant policy research and analysis, as well as having done legislative and regulatory analysis of related policy issues. Applicants should also have knowledge of other relevant public health, health services, and/or health policy topics. Strong research, writing, and presentation skills and the ability to work as part of a collaborative team and to be responsive under time pressure are essential for success in this position.
CRS works exclusively for the United States Congress, providing policy and legal analysis to committees and Members of both the House and Senate, regardless of party affiliation. As a legislative branch agency within the Library of Congress, CRS has been a valued and respected resource on Capitol Hill for more than a century.
CRS is well-known for analysis that is authoritative, confidential, objective, and nonpartisan. Its highest priority is to ensure that Congress has immediate access to the nation's best thinking on public policy issues of interest to its Members and committees.
The Congressional Research Service (CRS) is committed to building a diverse and inclusive workforce that ensures the Service is well positioned to anticipate and meet the information and analytical research needs of a 21st-century Congress.
Analyst duties include:
Prepares a variety of analytical, descriptive and background reports, memoranda, and written materials on subjects or public policy issues within the employee's designated areas of responsibility to support congressional decision-making.
Participates in planning, organizing, and coordinating group research efforts.
Through personal consultation, assists committees, Members, and staff with consideration of legislative issues by providing information and analysis, and by applying professional subject-area knowledge.
Participates in CRS seminars, workshops, and/or outreach programs for committees, Members, and staff.
Locates and provides information requested by Members and committees of Congress or their staff.
This position is located in the Congressional Research Service, Domestic Social Policy Division.
The position description number for this position is 004748.
This is a non-supervisory, bargaining unit position.
The salary range indicated reflects the locality pay adjustments for the Washington, D.C., Metropolitan area.
Library of Congress employees are prohibited from using illegal drugs, including marijuana. The Library is part of the Federal Government and abides by federal law, so regardless of individual state or District of Columbia laws, marijuana use is illegal, considered criminal activity, and can affect your employment at the Library. In addition, past or current drug use and activities (e.g., selling or distributing) may deem you ineligible for employment.
Applicants must have had progressively responsible experience and training sufficient in scope and quality to furnish them with an acceptable level of the following knowledge, skills, and abilities to perform the duties of the position without more than normal supervision.
Knowledge of biological products (e.g., biologics, biosimilars, vaccines, cellular and gene therapy), and applicable federal regulatory policy **
Ability to analyze public policy issues **
Ability to write in a public policy context **
Ability to convey analysis and information orally through briefings, consultations, and other presentations
Ability to lead collaborative research tasks
Ability to exercise objectivity in all phases of analysis and consultation
Ability to communicate effectively other than in writing
There are no education requirements for this posting.
Although it is the Library's policy to afford the maximum pay benefit to employees when setting rates of pay, a new appointee who has had no previous Federal service will generally be paid at step one of the grade.
The Library of Congress is an equal opportunity employer. Women, minorities, and persons with disabilities who meet eligibility requirements are strongly encouraged to apply.
Applicants must submit a complete application package that is received by the closing date of this announcement.
Appointment/retention is subject to a favorable evaluation of an appropriate personnel security/suitability investigation. For more information, please see:Vetting Process
This agency provides reasonable accommodation to applicants with disabilities. If you need a reasonable accommodation for any part of the application and hiring process, please email ADA@loc.gov. The decision on granting reasonable accommodation will be determined on a case-by-case basis.
Applicants with disabilities may be considered under special hiring procedures and must submit an appropriate certificate of eligibility when applying for this position. The proof or disability/certification may be issued by the State Vocational Rehabilitation Office, Disability Services or Career Services office of the applicant’s college or university, or the Department of Veterans Affairs. The letter must verify that the applicant has a severe disability and must be dated within three years of the date of the application. Certification from health care providers are not accepted. For more information contact the Library's Office of EEO/Diversity Programs at 202-707-6024 or email spp@loc.gov. FAILURE TO SUBMIT YOUR CERTIFICATION WILL CAUSE YOUR APPLICATION TO NOT BE CONSIDERED UNDER THE SELECTIVE PLACEMENT PROGRAM.
The Library of Congress is the national library of the United States and is part of the Legislative Branch of the Federal government. As such, all positions are in the excepted service.
The Library reserves the right to fill a lesser or greater number of vacancies indicated during the life of this vacancy announcement.
Initial permanent appointments to the Library of Congress require completion of a one-year probationary period. Probationary periods served at other Federal agencies do not count toward this requirement.
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A “Not to Exceed" (NTE) status is used to identify an appointment with a specific ending date. However, the Library has the right to separate a NTE employee at any time due to either performance issues or budget constraints.
Are you a veteran? Please indicate the type of veterans' preference you are claiming in your application materials and/or applicant profile and provide the appropriate supporting documentation to validate your claim. Those applying for 5-point preference must submit Member Copy 4 of your DD 214. Those applying for 10-point preference must fill out an SF-15 (click here for the form) and provide the required documentation listed on the back of the form. If required supporting documentation is not attached, Veterans' Preference will not be considered in the application process.
You will be evaluated for this job based on how well you meet the qualifications above.
The Library of Congress evaluates applicants through an applicant questionnaire and a structured interview. Applicants may also be screened for some jobs through licensing, certification, and/or education requirements, a narrative/application review, and/or a preliminary telephone interview. The knowledge, skills, and abilities (KSAs) that are marked with a double asterisk (**) in the vacancy announcement and the applicant questionnaire are considered the most critical for a position. To be considered for final selection, applicants must demonstrate fully acceptable experience in these designated KSAs in the narrative/application review, preliminary telephone and/or full structured interview. The various assessment tools listed above are designed to verify or explore applicants' experience, knowledge, and training directly related to the job in order to identify the best qualified applicants for selection.
For more information regarding eligibility requirements, please see the Library of Congress Merit Selection Plan, Section 8.5, at: Merit Selection Plan
Current or former federal employees must submit their most recent Notification of Personnel Action (SF-50 or equivalent).
Applicants with disabilities may be considered under special hiring procedures and must submit an appropriate certificate of eligibility when applying for this position. The proof or disability/certification may be issued by the State Vocational Rehabilitation Office, Disability Services or Career Services office of the applicant’s college or university, or the Department of Veterans Affairs. The letter must verify that the applicant has a severe disability and must be dated within three years of the date of the application. The program does not accept certification from health care providers. For more information contact the Library's Office of Equal Employment Opportunity and Diversity Programs at 202-707-6024 or email spp@loc.gov. FAILURE TO SUBMIT YOUR CERTIFICATION WILL CAUSE YOUR APPLICATION TO NOT BE CONSIDERED UNDER THE SELECTIVE PLACEMENT PROGRAM.
Please carefully follow all instructions under the How to Apply tab to ensure you are considered for the position.
You are required to apply online for this announcement. We are unable to accept mailed or emailed documents. You must complete the entire application process, including submission of all documents BEFORE this announcement closes. To do so, complete the following steps.
Step 1: If you do not already have one, create a resume on USAJOBS. Although you must enter your Social Security Number for USAJOBS, this information will not be provided to the Library of Congress.
Step 2: Review the Job Announcement. We recommend you go to the end of the Qualification and Evaluation section of the job announcement to preview the online questions that you will answer in Step 4. You may wish to customize your USAJOBS resume to ensure that it supports your responses to these questions.
Step 3: Click on the "APPLY ONLINE" button to the right of this announcement. Follow USAJOBS' instructions to access your account and submit your resume. You will be redirected to the Hiring Management website to complete the application process. If this is your first time in Hiring Management, you will be asked to answer questions related to your eligibility for Federal employment. You will be able to update this information and save it to our account for future announcements.
Step 4: Once you have completed the eligibility questions, you will be taken directly to the vacancy application questions. Answer all questions honestly and thoroughly.
Step 5: Hiring Management offers three options that will electronically attach your documentation to your online application once you finish answering the questions in the job announcement.
(1) You may select a document that you have already uploaded to USAJOBS for a previous announcement.
(2) You may electronically upload a document directly from your computer to your application. Be certain to review your complete application for confirmation of the document uploaded and click on "Finished" to be returned to USAJOBS.
IMPORTANT NOTE: If you have multiple documents of the same kind, e.g. 2 undergraduate transcripts from different schools or 2 SF-50s, etc., be sure that they are all in the same file on your computer or in your USAJOBS profile before uploading them. If you try uploading them individually, only the last one sent will be visible in our system. If you have any questions about this information, please contact the person on this announcement BEFORE the closing date.
Step 6: Click on "Finish" after you have completed your application. Once you have submitted your application, you can check your status online through your Hiring Management or MY USAJOBS account. Your complete online application and any required supplemental documentation (e.g., SF-50, etc.) must be received by 11:59 p.m. Eastern Standard Time (EST) on the closing date of the announcement. It is your responsibility to ensure that all documents are received on time and that the materials are readable. Failure to do so will result in your application being excluded from consideration for this announcement.
If you are experiencing any technical difficulty with the online process, you MUST CONTACT THE POINT OF CONTACT FOR THIS ANNOUNCEMENT BEFORE THE CLOSING DATE. For all technical issues please contact jobhelp@loc.gov , no later than 4:30pm EST of the Closing Date. REQUESTS FOR EXTENSIONS WILL NOT BE GRANTED.
Please review our evaluation process under Evaluation. You may check the status of your application for this position at any time by logging onto the USAJOBS "My USAJOBS" tab and clicking on "My Applications." You will receive final notification via e-mail when the vacancy has been filled.
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/job/760852900. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.
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The Library of Congress serves the Congress in fulfilling its duties and preserves and promotes knowledge and creativity for the benefit of the American people. It is the nation's oldest federal cultural institution and the world's largest library, with more than 158 million items in its physical collections (including books, manuscripts, prints, photos, film, video, and sound recordings) and over 37 million items online. Located primarily on Capitol Hill in Washington, D.C., the Library is the home of the U.S. Copyright Office, the Congressional Research Service (CRS), the Law Library of Congress, and the National Library Service for the Blind and Print Disabled.
