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Food and Drug Administration
Most recent job postings at Food and Drug Administration
via USAJobs
posted_at: 2 days agoschedule_type: Full-timesalary: 84,546 a year
This position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Medical Products and Tobacco (OMPTO), Office of Pharmaceutical Quality Operations (OPQO), which coordinates domestic and foreign inspectional, quality and investigational activities across the field and at headquarters.
This position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Medical Products and Tobacco (OMPTO), Office of Pharmaceutical Quality Operations (OPQO), which coordinates domestic and foreign inspectional, quality and investigational activities across the field and at headquarters.
Show more details...
via USAJobs
posted_at: 2 days agoschedule_type: Full-timesalary: 98,496 a year
This Direct-Hire position is in the Food and Drug Administration and is located in the Office of Scientific Coordination (OSC) which mission is to conduct peer-reviewed research and develop new scientific tools for the Food and Drug Administration (FDA) to improve public health..
This Direct-Hire position is in the Food and Drug Administration and is located in the Office of Scientific Coordination (OSC) which mission is to conduct peer-reviewed research and develop new scientific tools for the Food and Drug Administration (FDA) to improve public health..
Show more details...
via USAJobs
posted_at: 3 days agoschedule_type: Full-timesalary: 94,199 a year
This position is located in the Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Office of Blood Research and Review (OBRR) which regulates blood products, related drugs, and devices; reviews retroviral diagnostic tests; develops policies on blood product standards; participates in inspections; and conducts research.
This position is open to current permanent FDA employees only. This is a full-time, permanent
This position is located in the Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Office of Blood Research and Review (OBRR) which regulates blood products, related drugs, and devices; reviews retroviral diagnostic tests; develops policies on blood product standards; participates in inspections; and conducts research.
This position is open to current permanent FDA employees only. This is a full-time, permanent position. Show more details...
This position is open to current permanent FDA employees only. This is a full-time, permanent position. Show more details...
via Public Health Jobs
posted_at: 7 days agoschedule_type: Full-time
The Oak Ridge Institute for Science and Education (ORISE) Research Participation Programs at the U.S. Food and Drug Administration (FDA) are educational and training programs designed to provide undergraduate and graduate students, post-master and post-doctoral, and faculty opportunities to participate in project-specific research and developmental activities at the National Center for... Toxicological Research (NCTR). The FDA is responsible for protecting
The Oak Ridge Institute for Science and Education (ORISE) Research Participation Programs at the U.S. Food and Drug Administration (FDA) are educational and training programs designed to provide undergraduate and graduate students, post-master and post-doctoral, and faculty opportunities to participate in project-specific research and developmental activities at the National Center for... Toxicological Research (NCTR). The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation. The mission of NCTR is to conduct scientific research to develop and support innovative tools and evaluation of approaches that FDA uses to protect and promote individual and public health. To accomplish its mission, NCTR has established three strategic goals to ensure the conduct of innovative regulatory-science research vital to FDA. Regulatory Science-the science of developing and establishing tools, standards, and approaches to assess the safety, efficacy, quality, and performance of regulated products-is the foundation of decision-making at FDA. The three strategic goals are:
– Advance scientific approaches and tools required to support public health
– Promote global interactions in regulatory science research
– Improve administrative management and develop new communication materials and methods to support HHS/FDA science goals
This is an open announcement to collect applicants for future research opportunities. The opportunities include full-time, part-time, and summer appointments at NCTR. Contact ORISE.FDA.NCTR@orau.org for more information.
This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. Appointments can vary from a few months to one year, but may be renewed for up to three years upon recommendation of FDA, contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
See http://orise.orau.gov/fda/default.htm or http://www.fda.gov/ for more information.
Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.
FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency. This agreement covers such topics as the following:
– Non-employee nature of the ORISE appointment;
– Prohibition on ORISE Fellows performing inherently governmental functions;
– Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
– The fact that research materials and laboratory notebooks are the property of the FDA;
– ORISE fellow’s obligation to protect and not to further disclose or use non-public information.
Qualifications
Applicants must be enrolled as an undergraduate, graduate, or doctoral student at an accredited U.S. college or university pursuing a degree in a STEM discipline or have received a graduate or doctoral degree in a STEM discipline within five years of the start date of the appointment Show more details...
– Advance scientific approaches and tools required to support public health
– Promote global interactions in regulatory science research
– Improve administrative management and develop new communication materials and methods to support HHS/FDA science goals
This is an open announcement to collect applicants for future research opportunities. The opportunities include full-time, part-time, and summer appointments at NCTR. Contact ORISE.FDA.NCTR@orau.org for more information.
This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. Appointments can vary from a few months to one year, but may be renewed for up to three years upon recommendation of FDA, contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
See http://orise.orau.gov/fda/default.htm or http://www.fda.gov/ for more information.
Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.
FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency. This agreement covers such topics as the following:
– Non-employee nature of the ORISE appointment;
– Prohibition on ORISE Fellows performing inherently governmental functions;
– Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
– The fact that research materials and laboratory notebooks are the property of the FDA;
– ORISE fellow’s obligation to protect and not to further disclose or use non-public information.
Qualifications
Applicants must be enrolled as an undergraduate, graduate, or doctoral student at an accredited U.S. college or university pursuing a degree in a STEM discipline or have received a graduate or doctoral degree in a STEM discipline within five years of the start date of the appointment Show more details...
via LinkedIn
posted_at: 2 days agoschedule_type: Full-timesalary: 78,592–155,978 a year
To view the full vacancy annoucement, click here: https://www.fda.gov/media/165426/download
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: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
Introduction
The
To view the full vacancy annoucement, click here: https://www.fda.gov/media/165426/download
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: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
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 (OTC) and prescription drugs, including biological therapeutics and generic drugs.
The Office of Pharmaceutical Quality (OPQ) oversees and coordinates the overall regulation of pharmaceutical quality within CDER, including quality assessment of regulatory submission, manufacturing facility assessment, research, policy development, and surveillance of the quality of marketed pharmaceutical products.
The Office of Pharmaceutical Manufacturing Assessment (OPMA) assures the quality of pharmaceuticals are consistently manufactured over the product lifecycle and serves as OPQ’s centralized resource on pre- and post-approval inspections and manufacturing issues.
Duties/Responsibilities
As the Pharmaceutical Scientist, the incumbent is responsible for reviewing and evaluating comprehensive information and data on the manufacturing process and controls, microbiology controls and sterility assurance, and the implementation of the manufacturing control strategy at facilities submitted in Biologic License Agreements (BLAs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and supplemental BLAs, NDAs, as appropriate. The pharmaceutical scientist performs a full range of duties in one or more of the specialized areas described below, primarily monitoring the lifecycle of both innovator or biological products and generic or biosimilar drugs through a team-based evaluation and assessment of supplements and annual reports using risk management practices.
• Formulates recommendations and decisions in areas where precedents and guidelines are inadequate, utilizing scientific background and understanding of broad legislation, policy statements, and regulatory program definitions.
• Identifies and analyzes the role of the manufacturing process variables affecting pharmaceutical intermediates and finished products for various manufacturing processes through scientific or engineered approaches.
• Evaluates the adequacy of sponsors data and results for drug substance and drug product manufacturing and microbiology controls, including but not limited to in-process, release, stability data, and evaluates proposed product quality microbiology aspects of labeling as appropriate.
• Participates in facility inspections related to the evaluation of manufacturing processes and controls and in support of pre-approval and continuous good manufacturing practices (cGMP) inspections.
Supervisory Responsibilities: N/A
How to Apply
All qualified candidates should submit their resume with cover letter by March 1, 2023 to HireVue, our automated interview system. 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”. This pool of candidates by be used to fill vacant positions through June 30, 2023.
Job Reference ID: OPMA - Pharmaceutical Scientist
How You 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 OPQOPMARecruitment@fda.hhs.gov.
The U.S. Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer Show more details...
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: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
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 (OTC) and prescription drugs, including biological therapeutics and generic drugs.
The Office of Pharmaceutical Quality (OPQ) oversees and coordinates the overall regulation of pharmaceutical quality within CDER, including quality assessment of regulatory submission, manufacturing facility assessment, research, policy development, and surveillance of the quality of marketed pharmaceutical products.
The Office of Pharmaceutical Manufacturing Assessment (OPMA) assures the quality of pharmaceuticals are consistently manufactured over the product lifecycle and serves as OPQ’s centralized resource on pre- and post-approval inspections and manufacturing issues.
Duties/Responsibilities
As the Pharmaceutical Scientist, the incumbent is responsible for reviewing and evaluating comprehensive information and data on the manufacturing process and controls, microbiology controls and sterility assurance, and the implementation of the manufacturing control strategy at facilities submitted in Biologic License Agreements (BLAs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and supplemental BLAs, NDAs, as appropriate. The pharmaceutical scientist performs a full range of duties in one or more of the specialized areas described below, primarily monitoring the lifecycle of both innovator or biological products and generic or biosimilar drugs through a team-based evaluation and assessment of supplements and annual reports using risk management practices.
• Formulates recommendations and decisions in areas where precedents and guidelines are inadequate, utilizing scientific background and understanding of broad legislation, policy statements, and regulatory program definitions.
• Identifies and analyzes the role of the manufacturing process variables affecting pharmaceutical intermediates and finished products for various manufacturing processes through scientific or engineered approaches.
• Evaluates the adequacy of sponsors data and results for drug substance and drug product manufacturing and microbiology controls, including but not limited to in-process, release, stability data, and evaluates proposed product quality microbiology aspects of labeling as appropriate.
• Participates in facility inspections related to the evaluation of manufacturing processes and controls and in support of pre-approval and continuous good manufacturing practices (cGMP) inspections.
Supervisory Responsibilities: N/A
How to Apply
All qualified candidates should submit their resume with cover letter by March 1, 2023 to HireVue, our automated interview system. 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”. This pool of candidates by be used to fill vacant positions through June 30, 2023.
Job Reference ID: OPMA - Pharmaceutical Scientist
How You 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 OPQOPMARecruitment@fda.hhs.gov.
The U.S. Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer Show more details...
via LinkedIn
posted_at: 19 hours agoschedule_type: Full-timesalary: 132,368 a year
To view the full vacancy annoucement, click here: https://www.fda.gov/media/165591/download
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 compensated under the provisions of this authority. Additional information on... 21st Century Cures Act can be found here: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
Introduction
The
To view the full vacancy annoucement, click here: https://www.fda.gov/media/165591/download
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 compensated under the provisions of this authority. Additional information on... 21st Century Cures Act can be found here: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
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 (OTC) and prescription
drugs, including biological therapeutics and generic drugs.
The Office of Strategic Programs (OSP) is responsible for quantitative and qualitative data analysis, program evaluation, business process modernization, decision support services to facilitate effective operations, consultation to Center Offices in developing strategic and operational plans for CDER, cross-center management and coordination of work on Center- wide governance and special initiatives, and the implementation of IT solutions to meet CDER’s business needs. OSP provides essential expert support and enabling services for CDER to meet its mission objectives.
Business Informatics Governance Staff (BIGS) oversees the development and management of the CDER enterprise-wide IT strategy; develops strategic roadmaps aligned with the IT strategy to modernize and innovate CDER’s drug regulatory operations. This position is in the CDER Immediate Office supporting the Business Informatics Governance Board’s (BIG) Informatics Program Management Office (IPMO).
Duties/Responsibilities
As an Informatics Program Manager, the incumbent will support the planning and execution of major technology programs consisting of multiple projects:
• Independently applies subject matter expertise and proper analytical resources to uncover the root cause of program issues, recognizes if there is any potential overlap between ongoing work, and, if necessary, engages in aspects of problem-solving methods and/or processes using conventional ideas, insights, programs, and/or technologies to execute the work requested while maximizing resources.
• Applies change management techniques and approaches to problems and/or situations related to projects in his/her purview through understanding the role change management techniques plays to support objectives of the technology transformation.
• Leads multiple major complex technology projects within a portfolio and monitors the management of costs, adherence to spending plan, and execution of time management, prioritization, document management, and knowledge management resources in order to ensure the maximum Return on Investment (ROI) and successful completion of programs.
Supervisory Responsibilities: N/A
How to Apply
Submit resume with cover letter and transcripts by March 16, 2023 to: CDEROSPRecruitment@fda.hhs.gov. Candidate resumes may be shared with hiring official within the Center for Drug Evaluation and Research (CDER) with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”. For questions, please contact CDER OSP Recruitment Team at CDEROSPRecruitment@fda.hhs.gov. Please reference “INFORMATICS PROGRAM MANAGER OSP/BIGS” in the subject-line when applying or submitting questions.
Announcement Contact
For questions regarding this Cures position, please contact CDEROSPRecruitment@fda.hhs.gov.
The U.S. Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer Show more details...
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 compensated under the provisions of this authority. Additional information on... 21st Century Cures Act can be found here: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
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 (OTC) and prescription
drugs, including biological therapeutics and generic drugs.
The Office of Strategic Programs (OSP) is responsible for quantitative and qualitative data analysis, program evaluation, business process modernization, decision support services to facilitate effective operations, consultation to Center Offices in developing strategic and operational plans for CDER, cross-center management and coordination of work on Center- wide governance and special initiatives, and the implementation of IT solutions to meet CDER’s business needs. OSP provides essential expert support and enabling services for CDER to meet its mission objectives.
Business Informatics Governance Staff (BIGS) oversees the development and management of the CDER enterprise-wide IT strategy; develops strategic roadmaps aligned with the IT strategy to modernize and innovate CDER’s drug regulatory operations. This position is in the CDER Immediate Office supporting the Business Informatics Governance Board’s (BIG) Informatics Program Management Office (IPMO).
Duties/Responsibilities
As an Informatics Program Manager, the incumbent will support the planning and execution of major technology programs consisting of multiple projects:
• Independently applies subject matter expertise and proper analytical resources to uncover the root cause of program issues, recognizes if there is any potential overlap between ongoing work, and, if necessary, engages in aspects of problem-solving methods and/or processes using conventional ideas, insights, programs, and/or technologies to execute the work requested while maximizing resources.
• Applies change management techniques and approaches to problems and/or situations related to projects in his/her purview through understanding the role change management techniques plays to support objectives of the technology transformation.
• Leads multiple major complex technology projects within a portfolio and monitors the management of costs, adherence to spending plan, and execution of time management, prioritization, document management, and knowledge management resources in order to ensure the maximum Return on Investment (ROI) and successful completion of programs.
Supervisory Responsibilities: N/A
How to Apply
Submit resume with cover letter and transcripts by March 16, 2023 to: CDEROSPRecruitment@fda.hhs.gov. Candidate resumes may be shared with hiring official within the Center for Drug Evaluation and Research (CDER) with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”. For questions, please contact CDER OSP Recruitment Team at CDEROSPRecruitment@fda.hhs.gov. Please reference “INFORMATICS PROGRAM MANAGER OSP/BIGS” in the subject-line when applying or submitting questions.
Announcement Contact
For questions regarding this Cures position, please contact CDEROSPRecruitment@fda.hhs.gov.
The U.S. Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer Show more details...
via LinkedIn
posted_at: 3 days agoschedule_type: Full-timesalary: 78,592–94,199 a year
To view the full vacancy annoucement, click here: https://www.fda.gov/media/165509/download
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: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
Introduction
The
To view the full vacancy annoucement, click here: https://www.fda.gov/media/165509/download
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: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
Introduction
The Food and Drug Administration (FDA or Agency) 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 Center for Biologics Evaluation and Research (CBER) is a Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. CBER’s mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. CBER protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.
Duties/Responsibilities
The incumbent serves the Communication Technology Branch (CTB), Division of Communication and Consumer Affairs (DCCA) in the Office of Communication, Outreach, and Development (OCOD). The DCCA directs and implements Center consumer and professional informational activities. The Division identifies, plans, and develops informational and outreach programs as well as creates content development, design, policy, and management of Center's Internet and Intranet web sites.
Specifically, the incumbent will:
• Plan, oversee, implement and evaluates the content development and evaluation of CBER web products and services. This includes setting goals and objectives, assisting in formulating and implementing a strategic vision, conceiving policies and strategies and assisting in the operation of the Agency's web site.
• Identify user-centered design, information architecture, and communication issues on CBER component web sites and works with content owners to improve the sites.
• Serve as a content manager liaison to FDA Web Communication efforts and CBER offices.
• Ensures documents are prepared or finalized in accordance with Section 508 compliance requirements.
• Prepare special and recurring reports as required.
How to Apply
Please submit electronic resume or curriculum vitae (please be sure to clearly define the number of years using month and year training completed, in addition to describing duties performed during that time period), copy of your unoffical transcripts (if applicable), SF-50 (if applicable), latest PMAP (if applicable), and letter of interest with “CURES CBER/OCOD/DCCA/CTB Technical Information Specialist” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through March 21, 2023.
Announcement Contact
For questions regarding this Cures position, please contact: CBERHumanCapital@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 Show more details...
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: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
Introduction
The Food and Drug Administration (FDA or Agency) 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 Center for Biologics Evaluation and Research (CBER) is a Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. CBER’s mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. CBER protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.
Duties/Responsibilities
The incumbent serves the Communication Technology Branch (CTB), Division of Communication and Consumer Affairs (DCCA) in the Office of Communication, Outreach, and Development (OCOD). The DCCA directs and implements Center consumer and professional informational activities. The Division identifies, plans, and develops informational and outreach programs as well as creates content development, design, policy, and management of Center's Internet and Intranet web sites.
Specifically, the incumbent will:
• Plan, oversee, implement and evaluates the content development and evaluation of CBER web products and services. This includes setting goals and objectives, assisting in formulating and implementing a strategic vision, conceiving policies and strategies and assisting in the operation of the Agency's web site.
• Identify user-centered design, information architecture, and communication issues on CBER component web sites and works with content owners to improve the sites.
• Serve as a content manager liaison to FDA Web Communication efforts and CBER offices.
• Ensures documents are prepared or finalized in accordance with Section 508 compliance requirements.
• Prepare special and recurring reports as required.
How to Apply
Please submit electronic resume or curriculum vitae (please be sure to clearly define the number of years using month and year training completed, in addition to describing duties performed during that time period), copy of your unoffical transcripts (if applicable), SF-50 (if applicable), latest PMAP (if applicable), and letter of interest with “CURES CBER/OCOD/DCCA/CTB Technical Information Specialist” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through March 21, 2023.
Announcement Contact
For questions regarding this Cures position, please contact: CBERHumanCapital@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 Show more details...
via LinkedIn
posted_at: 10 days agoschedule_type: Full-timesalary: 126,233 a year
To view the full vacancy annoucement, click here: https://www.fda.gov/media/165379/download
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: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
Introduction
The
To view the full vacancy annoucement, click here: https://www.fda.gov/media/165379/download
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: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
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 (OTC) and prescription drugs, including biological therapeutics and generic drugs.
The mission of the Office of Compliance (OC) is to shield patients from poor quality, unsafe and ineffective drugs through proactive compliance strategies and risk-based enforcement actions. CDER OC strives to be a model of efficiency, innovation, and operational excellence. Guided by law and science, the Office makes strategic and risk-based decisions, communicates clearly with all stakeholders, fosters global collaboration, promotes voluntary compliance, and takes decisive action.
The Office of Compounding Quality and Compliance (OCQC) aims to protect patients from unsafe, ineffective, and poor-quality compounded drugs, while preserving access to lawfully marketed compounded drugs for patients who have a medical need for them. OCQC works to protect consumers from unsafe compounded drugs, develop and implement the Compounding Quality Center of Excellence focused on improving the quality of compounded drugs, and develop and implement policies and compliance strategies to protect the public health by helping assure the quality of compounded drugs.
The Consumer Safety Officer (Special Assistant) is in a unique position to address overarching issues that impact the three (3) divisions and six (6) branches of OCQC, leading the development and implementing projects and initiatives that cut across the office.
Duties/Responsibilities
As a Consumer Safety Officer (Special Assistant) in the Office of Compounding and Quality Compliance (OCQC) and the Immediate Office, the incumbent will be responsible for developing and implementing compliance strategies, programs, policies, and communications for protecting the public health that minimize exposure to unsafe, ineffective, and poor-quality compounded drug products while preserving access to lawfully marketed compounded drugs for patients who have a medical need for them.
• Works closely with Office Director and Office Deputy Director to develop assignments, projects initiatives and responses to urgent, controversial, high profile cross cutting requests, involving compounded drugs. Because of the broad compliance, policy, and enforcement responsibilities of the Office of Compounding and Quality Compliance (OCQC), the workload is variable, crosscutting and often complex, requiring directed and urgent action.
• Identifies and assesses emerging, standing, or precedent-setting issues and their potential or real impact on Office procedures, policies, activities, and resources that impact all OCQC, the three (3) divisions and six (6) branches. Makes decisions concerning work priorities; deciding which issues must be addressed immediately and reprioritizing current work. Monitors the workflow to see that the set priorities are met.
• Performs, facilitates, or leads special assignments, projects, and initiatives on matters that cross OCQC such as projects and initiatives addressing the active pharmaceutical ingredients (APIs) used to compound drugs. For example, this initiative addressing the use of APIs by compounders requires consensus and collaboration among the three (3) divisions on potential adulteration issues, misbranding and the conditions of sections 503A and 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act as well as policy and outreach implications. As the compounding program evolves and matures, additional complex compounding compliance issues involving multiple entities throughout the office, Agency, government, Congress, and are driven by the need to protect public health will arise. After consensus within the office, assignments then often involve multiple inter-personal contacts within Agency and FDA, Federal, local health authorities, the regulated industry, healthcare professionals and the public for input and implementation.
• Research appropriate sources to develop briefing papers, projects, and initiatives and weighs the probable consequences of various approaches and provides recommendations to high level officials.
• Keeps abreast of new legislature, regulations, and policy that may impact OCQC activities, programs, and initiatives. Examines the impact between these future changes and the interface with current policies, practices, and programs. Advises the Director accordingly. Provides expert advice on policy and procedure to the Director. Develops and implements new policies and procedures and identifies critical initiatives as needed.
• Interacts with a variety of technical, scientific, public health, regulatory and administrative professionals on OCQC issues and policies across the Agency, other governmental organizations, the national and international pharmaceutical industry, and public and private entity representatives.
• Researches and prepares written and oral reports on OCQC activities throughout the Office and Agency. Prepares studies on a variety of topics including OCQC legislation, policies, projects, and special initiatives. Monitors Compounding activities and attends to emerging problems or issues that affect the direction or outcome of OCQC goals and objectives. Develops solutions or recommendations to modify or change the approach if needed and presents findings to senior management.
Supervisory Responsibilities: N/A
How to Apply
Submit resume with cover letter and transcripts by February 24, 2023 to: CDER-OC-OCQC-RECRUITMENT@fda.hhs.gov. Candidate resumes may be shared with hiring official within the Center for Drug Evaluation and Research (CDER) with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”. For questions, please contact CDER OC PMAS OCQC Team at CDER-OC-OCQC-RECRUITMENT@fda.hhs.gov. Please reference “Special Assistant for OCQC” in the subject when applying or submitting questions.
Announcement Contact
For questions regarding this Cures position, please contact CDER-OC-OCQC-RECRUITMENT@fda.hhs.gov.
The U.S. Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer Show more details...
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: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
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 (OTC) and prescription drugs, including biological therapeutics and generic drugs.
The mission of the Office of Compliance (OC) is to shield patients from poor quality, unsafe and ineffective drugs through proactive compliance strategies and risk-based enforcement actions. CDER OC strives to be a model of efficiency, innovation, and operational excellence. Guided by law and science, the Office makes strategic and risk-based decisions, communicates clearly with all stakeholders, fosters global collaboration, promotes voluntary compliance, and takes decisive action.
The Office of Compounding Quality and Compliance (OCQC) aims to protect patients from unsafe, ineffective, and poor-quality compounded drugs, while preserving access to lawfully marketed compounded drugs for patients who have a medical need for them. OCQC works to protect consumers from unsafe compounded drugs, develop and implement the Compounding Quality Center of Excellence focused on improving the quality of compounded drugs, and develop and implement policies and compliance strategies to protect the public health by helping assure the quality of compounded drugs.
The Consumer Safety Officer (Special Assistant) is in a unique position to address overarching issues that impact the three (3) divisions and six (6) branches of OCQC, leading the development and implementing projects and initiatives that cut across the office.
Duties/Responsibilities
As a Consumer Safety Officer (Special Assistant) in the Office of Compounding and Quality Compliance (OCQC) and the Immediate Office, the incumbent will be responsible for developing and implementing compliance strategies, programs, policies, and communications for protecting the public health that minimize exposure to unsafe, ineffective, and poor-quality compounded drug products while preserving access to lawfully marketed compounded drugs for patients who have a medical need for them.
• Works closely with Office Director and Office Deputy Director to develop assignments, projects initiatives and responses to urgent, controversial, high profile cross cutting requests, involving compounded drugs. Because of the broad compliance, policy, and enforcement responsibilities of the Office of Compounding and Quality Compliance (OCQC), the workload is variable, crosscutting and often complex, requiring directed and urgent action.
• Identifies and assesses emerging, standing, or precedent-setting issues and their potential or real impact on Office procedures, policies, activities, and resources that impact all OCQC, the three (3) divisions and six (6) branches. Makes decisions concerning work priorities; deciding which issues must be addressed immediately and reprioritizing current work. Monitors the workflow to see that the set priorities are met.
• Performs, facilitates, or leads special assignments, projects, and initiatives on matters that cross OCQC such as projects and initiatives addressing the active pharmaceutical ingredients (APIs) used to compound drugs. For example, this initiative addressing the use of APIs by compounders requires consensus and collaboration among the three (3) divisions on potential adulteration issues, misbranding and the conditions of sections 503A and 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act as well as policy and outreach implications. As the compounding program evolves and matures, additional complex compounding compliance issues involving multiple entities throughout the office, Agency, government, Congress, and are driven by the need to protect public health will arise. After consensus within the office, assignments then often involve multiple inter-personal contacts within Agency and FDA, Federal, local health authorities, the regulated industry, healthcare professionals and the public for input and implementation.
• Research appropriate sources to develop briefing papers, projects, and initiatives and weighs the probable consequences of various approaches and provides recommendations to high level officials.
• Keeps abreast of new legislature, regulations, and policy that may impact OCQC activities, programs, and initiatives. Examines the impact between these future changes and the interface with current policies, practices, and programs. Advises the Director accordingly. Provides expert advice on policy and procedure to the Director. Develops and implements new policies and procedures and identifies critical initiatives as needed.
• Interacts with a variety of technical, scientific, public health, regulatory and administrative professionals on OCQC issues and policies across the Agency, other governmental organizations, the national and international pharmaceutical industry, and public and private entity representatives.
• Researches and prepares written and oral reports on OCQC activities throughout the Office and Agency. Prepares studies on a variety of topics including OCQC legislation, policies, projects, and special initiatives. Monitors Compounding activities and attends to emerging problems or issues that affect the direction or outcome of OCQC goals and objectives. Develops solutions or recommendations to modify or change the approach if needed and presents findings to senior management.
Supervisory Responsibilities: N/A
How to Apply
Submit resume with cover letter and transcripts by February 24, 2023 to: CDER-OC-OCQC-RECRUITMENT@fda.hhs.gov. Candidate resumes may be shared with hiring official within the Center for Drug Evaluation and Research (CDER) with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”. For questions, please contact CDER OC PMAS OCQC Team at CDER-OC-OCQC-RECRUITMENT@fda.hhs.gov. Please reference “Special Assistant for OCQC” in the subject when applying or submitting questions.
Announcement Contact
For questions regarding this Cures position, please contact CDER-OC-OCQC-RECRUITMENT@fda.hhs.gov.
The U.S. Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer Show more details...
via LinkedIn
posted_at: 18 days agoschedule_type: Full-time
This position is being filled under an excepted 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 the authority. Additional information on 21st Century Cures Act can be found here... https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
View full vacancy
This position is being filled under an excepted 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 the authority. Additional information on 21st Century Cures Act can be found here... https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
View full vacancy announcement here: https://www.fda.gov/media/165190/download
Introduction
The Food and Drug Administration (FDA) is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are 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 (OTC) and prescription drugs, including biological therapeutics and generic drugs.
The Office of Strategic Programs (OSP) is responsible for quantitative and qualitative data analysis, program evaluation, business process modernization, decision support services to facilitate effective operations, consultation to Center Offices in developing strategic and operational plans for CDER, cross-center management and coordination of work on Center-wide governance and special initiatives, and the implementation of IT solutions to meet CDER’s business needs. OSP provides essential expert support and enabling services for CDER to meet its mission objectives.
Office of Program and Strategic Analysis (OPSA) is responsible for quantitative and qualitative data analysis, business process analysis and improvement, and program evaluation to support senior management decisions. OPSA provides consultation services to Center Offices in developing and implementing proposals for key strategic initiatives and priorities, evaluating the impact of operations and policies on external stakeholders, and in conducting evaluation studies to inform Center strategy and policy position on emerging issues in drug regulation.
This position is located in the Lean Management Staff (LMS), Office of Program and Strategic Analysis (OPSA) within the Office of Strategic Programs (OSP) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA).
Duties/Responsibilities
As a Social Scientist, the incumbent supports the conceptualization, design, and conduct of complex studies into any aspect of the operation and management of programs and/or processes within the Center. This includes the identification of actual or potential problems, trends, and similar factors in Center operations and recommend solutions to senior management for consideration. This work will provide a basis for, and have a direct effect on, decisions affecting major Center regulatory policies, processes, and programs. The incumbent will perform the following duties:
Band A:
• Assists the team and participates in the assessment of change readiness and the development of a comprehensive and overarching change management strategy that enables the realization of the intended future state.
• Works closely with senior staff and assists in stakeholder analysis to identify and recommend when and how the team should leverage stakeholders and champions of change to further project objectives and implementation efforts.
Band B:
• Meets duties and responsibilities outlined in Band A above. • Evaluates the customer’s readiness for change (i.e., identifying barriers and strengths) and implements coordinated and thoughtful change management strategies that appropriately address the operational gaps and process changes which are a by-product of various projects. In simpler situations, the analyst manages components of a change management plan (i.e., communication tools, timelines, outputs, etc.) and leverages the proper strategic communications techniques with internal and external customers.
• Anticipates implementation need, validates with supervisor, supports, and reviews the created implementation plan or methodology. This will drive the team towards the successful implementation of a solution and outlines phases, including data support, stakeholders, systems needed, processes, and other relevant factors.
Band C
• Meets duties and responsibilities outlined in Band B above.
• Assesses and evaluates the customer’s readiness for change (i.e., identifying barriers/strengths) and implements coordinated and thoughtful change management strategies that appropriately address the gaps and process changes resulting from the transition to the future state. Oversees the management and modification of all components of a change management plan (i.e., communication tools, timelines, outputs, etc.) and leverages the proper strategic communications techniques with internal and external customers.
• Identifies options, incorporates findings, and deploys methodologies to solve challenging problems and assist in the improvement of current or future programs, initiatives, and/or processes. Identifies potentially unintended side effects and suggests feasible solutions. Provides input to ad-hoc analyses that lend insight into potential problems, trends, and solutions at the Center level, e.g., trends in the accelerated approval program, imbalances between workload and resources, drug safety oversight, etc.
Supervisory Responsibilities: N/A
How to Apply
Submit resume with cover letter and transcripts by February 20, 2023, to: CDEROSPRecruitment@fda.hhs.gov. Candidate resumes may be shared with hiring official within the Center for Drug Evaluation and Research (CDER) with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”. For questions, please contact CDER OSP Recruitment Team at CDEROSPRecruitment@fda.hhs.gov. Please reference “Social Scientist OSP/LMS” in the subject-line when applying or submitting questions.
Announcement Contact
For questions regarding this Cures position, please contact CDEROSPRecruitment@fda.hhs.gov.
The U.S. Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer Show more details...
View full vacancy announcement here: https://www.fda.gov/media/165190/download
Introduction
The Food and Drug Administration (FDA) is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are 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 (OTC) and prescription drugs, including biological therapeutics and generic drugs.
The Office of Strategic Programs (OSP) is responsible for quantitative and qualitative data analysis, program evaluation, business process modernization, decision support services to facilitate effective operations, consultation to Center Offices in developing strategic and operational plans for CDER, cross-center management and coordination of work on Center-wide governance and special initiatives, and the implementation of IT solutions to meet CDER’s business needs. OSP provides essential expert support and enabling services for CDER to meet its mission objectives.
Office of Program and Strategic Analysis (OPSA) is responsible for quantitative and qualitative data analysis, business process analysis and improvement, and program evaluation to support senior management decisions. OPSA provides consultation services to Center Offices in developing and implementing proposals for key strategic initiatives and priorities, evaluating the impact of operations and policies on external stakeholders, and in conducting evaluation studies to inform Center strategy and policy position on emerging issues in drug regulation.
This position is located in the Lean Management Staff (LMS), Office of Program and Strategic Analysis (OPSA) within the Office of Strategic Programs (OSP) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA).
Duties/Responsibilities
As a Social Scientist, the incumbent supports the conceptualization, design, and conduct of complex studies into any aspect of the operation and management of programs and/or processes within the Center. This includes the identification of actual or potential problems, trends, and similar factors in Center operations and recommend solutions to senior management for consideration. This work will provide a basis for, and have a direct effect on, decisions affecting major Center regulatory policies, processes, and programs. The incumbent will perform the following duties:
Band A:
• Assists the team and participates in the assessment of change readiness and the development of a comprehensive and overarching change management strategy that enables the realization of the intended future state.
• Works closely with senior staff and assists in stakeholder analysis to identify and recommend when and how the team should leverage stakeholders and champions of change to further project objectives and implementation efforts.
Band B:
• Meets duties and responsibilities outlined in Band A above. • Evaluates the customer’s readiness for change (i.e., identifying barriers and strengths) and implements coordinated and thoughtful change management strategies that appropriately address the operational gaps and process changes which are a by-product of various projects. In simpler situations, the analyst manages components of a change management plan (i.e., communication tools, timelines, outputs, etc.) and leverages the proper strategic communications techniques with internal and external customers.
• Anticipates implementation need, validates with supervisor, supports, and reviews the created implementation plan or methodology. This will drive the team towards the successful implementation of a solution and outlines phases, including data support, stakeholders, systems needed, processes, and other relevant factors.
Band C
• Meets duties and responsibilities outlined in Band B above.
• Assesses and evaluates the customer’s readiness for change (i.e., identifying barriers/strengths) and implements coordinated and thoughtful change management strategies that appropriately address the gaps and process changes resulting from the transition to the future state. Oversees the management and modification of all components of a change management plan (i.e., communication tools, timelines, outputs, etc.) and leverages the proper strategic communications techniques with internal and external customers.
• Identifies options, incorporates findings, and deploys methodologies to solve challenging problems and assist in the improvement of current or future programs, initiatives, and/or processes. Identifies potentially unintended side effects and suggests feasible solutions. Provides input to ad-hoc analyses that lend insight into potential problems, trends, and solutions at the Center level, e.g., trends in the accelerated approval program, imbalances between workload and resources, drug safety oversight, etc.
Supervisory Responsibilities: N/A
How to Apply
Submit resume with cover letter and transcripts by February 20, 2023, to: CDEROSPRecruitment@fda.hhs.gov. Candidate resumes may be shared with hiring official within the Center for Drug Evaluation and Research (CDER) with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”. For questions, please contact CDER OSP Recruitment Team at CDEROSPRecruitment@fda.hhs.gov. Please reference “Social Scientist OSP/LMS” in the subject-line when applying or submitting questions.
Announcement Contact
For questions regarding this Cures position, please contact CDEROSPRecruitment@fda.hhs.gov.
The U.S. Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer Show more details...
via LinkedIn
posted_at: 10 days agoschedule_type: Full-timesalary: 165,000–262,150 a year
To view the full vacancy annoucement, click here: https://www.fda.gov/media/165380/download
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: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
Introduction
The
To view the full vacancy annoucement, click here: https://www.fda.gov/media/165380/download
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: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
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 Office of New Drugs (OND) is a super office within CDER and responsible for the assessment of new drugs and therapeutic biologics. OND provides clinical, nonclinical, and regulatory expertise on the full range of drugs and therapeutic biologics that can be made available to the American people.
The Office of New Drug Policy (ONDP) provides regulatory policy and clinical policy support services to Office of New Drugs (OND) staff; aligns OND staff on regulatory standards; and identifies, develops, and advances strategic new drug policy priorities.
The Division of Clinical Policy (DCP) oversees new drug clinical policy, including developing new drug clinical and labeling policy and ensuring OND clinical expertise is reflected in policy development undertaken by components outside of OND.
The Labeling Policy Team (LPT) in DCP oversees implementation of Prescribing Information regulations and guidance’s to help promote consistency in labeling practices across CDER.
Duties/Responsibilities
As a Physician on the LPT, the incumbent helps oversee the implementation of prescription drug labeling regulations, FDA labeling guidance, and CDER labeling policies across several clinical prescription drug review divisions, to help ensure that the labeling:
• Supports several Associate Directors for Labeling (ADLs) with their review and development of labeling in the clinical prescription drug review divisions.
• Recommends solutions to address labeling issues.
• Assists in the development and maintenance of labeling review resources (e.g., Labeling Review Tool) for CDER staff and public stakeholders.
• Participates in and leads labeling policy initiatives such as labeling policy working groups and labeling guidance’s.
• Helps ensure the quality of the labeling review comments to applicants (e.g., FDA’s rationale for changes to the applicant’s proposals).
Supervisory Responsibilities: N/A
How to Apply
How to Apply: Submit resume or curriculum vitae with cover letter by February 28, 2023, to: Danielle Harris at ONDIORecruitment@fda.hhs.gov . Candidate resumes may be shared with hiring official within the CDER with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”. Please reference Job Reference ID: ONDP-DCP-LPT-001.
Announcement Contact
For questions regarding this Cures position, please contact Danielle Harris at ONDIORecruitment@fda.hhs.gov .
The U.S. Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer Show more details...
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: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
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 Office of New Drugs (OND) is a super office within CDER and responsible for the assessment of new drugs and therapeutic biologics. OND provides clinical, nonclinical, and regulatory expertise on the full range of drugs and therapeutic biologics that can be made available to the American people.
The Office of New Drug Policy (ONDP) provides regulatory policy and clinical policy support services to Office of New Drugs (OND) staff; aligns OND staff on regulatory standards; and identifies, develops, and advances strategic new drug policy priorities.
The Division of Clinical Policy (DCP) oversees new drug clinical policy, including developing new drug clinical and labeling policy and ensuring OND clinical expertise is reflected in policy development undertaken by components outside of OND.
The Labeling Policy Team (LPT) in DCP oversees implementation of Prescribing Information regulations and guidance’s to help promote consistency in labeling practices across CDER.
Duties/Responsibilities
As a Physician on the LPT, the incumbent helps oversee the implementation of prescription drug labeling regulations, FDA labeling guidance, and CDER labeling policies across several clinical prescription drug review divisions, to help ensure that the labeling:
• Supports several Associate Directors for Labeling (ADLs) with their review and development of labeling in the clinical prescription drug review divisions.
• Recommends solutions to address labeling issues.
• Assists in the development and maintenance of labeling review resources (e.g., Labeling Review Tool) for CDER staff and public stakeholders.
• Participates in and leads labeling policy initiatives such as labeling policy working groups and labeling guidance’s.
• Helps ensure the quality of the labeling review comments to applicants (e.g., FDA’s rationale for changes to the applicant’s proposals).
Supervisory Responsibilities: N/A
How to Apply
How to Apply: Submit resume or curriculum vitae with cover letter by February 28, 2023, to: Danielle Harris at ONDIORecruitment@fda.hhs.gov . Candidate resumes may be shared with hiring official within the CDER with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”. Please reference Job Reference ID: ONDP-DCP-LPT-001.
Announcement Contact
For questions regarding this Cures position, please contact Danielle Harris at ONDIORecruitment@fda.hhs.gov .
The U.S. Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer Show more details...
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