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This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority.
Additional information on 21st Century Cures Act can be found here:
21st Century Cures Act Information
Introduction
The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.
The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
The mission of the Office of Regulatory Policy (ORP) is to provide Center oversight and leadership in the development of regulations, policies, procedures, and guidance’s that affect the drug approval process, and in the development of new legislation. Also, ORP manages the disclosure of official records and information under the Freedom of Information Act, Privacy Act, other statutes, and Food and Drug Administration’s public disclosure regulations.
The mission of the Division of Disclosure Policy (DIDP) is to provide Center oversight and leadership in the disclosure of official records and information under the Freedom of Information Act, Privacy Act, other statutes, and FDA's public disclosure regulations.
Duties/Responsibilities
As a Scientific Redactor, the incumbent will apply redaction skills and good judgment in appropriately redacting scientifically rich information and documents by identifying and removing confidential information before public disclosure. Informed or awareness of scientific terminology and concepts and may be required to consult with FDA’s program areas on important and sensitive issues and inform the supervisor of sensitive and/or challenging requests.
Band A:
Ensures that all responses are accurate and contain only information which is disclosable as provided under the Freedom of Information Act (FOIA) and FDA policy. FOIA requests and other disclosure projects are assessed, evaluated, and completed in a timely manner. Reviews and organizes materials, documents, and records for disclosure to ensure that they are accurate, clear, and concise.
Evaluates information to ensure that it is complete and accurate and follows up to make sure that agreements and commitments are fulfilled in a timely manner. Plan and organize requests for information and manage multiple tasks simultaneously. Sets clear priorities, goals and expectations, tracks progress against goals, ensures feedback and addresses problems and issues promptly by maintaining a good working relationship with supervisor and team leader.
Utilizes processes and methods of collecting and synthesizing information from various sources in an objective, unbiased manner; understands, interprets, and makes sound decisions relative to information disclosure.
Analyzes information needs, determines an information plan, and, by careful evaluation, ensures that information is within the guidelines provided for under the Freedom of Information Act, Trade Secrets Act, Federal Food, Drug and Cosmetic (FD&C) Act and related statutes and regulations implemented by FDA.
Maintains an awareness of current developments in CDER and uses this knowledge in the process of assembling appropriate information for disclosure. Seeks information to understand problems, needs and expectations and methodically and systematically establishes reliable data to support disclosure decisions.
Applies knowledge to appropriately identify issues, problems, or opportunities, and determines if action is needed. Applies investigative techniques to acquire new data. Applies useful, accurate and comprehensive models and methods. Works cooperatively with others to share information and to build and maintain mutually beneficial partnerships to accomplish objectives and achieve results.
Provides support to agency representatives from the Office of Chief Counsel in the collection and/or preparation of background information and testimony of FDA officials in court cases on defending FDA’s position on the disclosure of requested information. Prepares recommendation for document request denials for information exempt from disclosure.
Recommendations must include technical justifications and appropriate evidentiary support. Consults with appropriate FDA components to assure that information requests are complete and satisfied in a timely manner. Works as collaborative team member in discussing and addressing issues related to information disclosures.
Supervisory Responsibilities: N/A
How to Apply
Submit resume or curriculum vitae with cover letter by October 31, 2024, to: CDER-ORP-Cures-Hiring@fda.hhs.gov. On the subject line, please reference “Scientific Redactor Band A”. Candidate resumes may be shared with hiring officials within CDER with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”.
How I Will Be Evaluated
Candidates may be evaluated based on an interview, review of requested work samples, writing samples, most recent performance evaluation(s), professional references, results of an oral presentation or work-related test. Failure to comply with any of the additional assessment requirements will result in removal from further consideration.
Announcement Contact
For questions regarding this Cures position, please contact CDER-ORP-Cures-Hiring@fda.hhs.gov.
The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer.
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