FDA - Physician - Clinical Reviewer - Hematology/Oncology
1 week ago
FDA – Center for Drug Evaluation and Research (CDER)
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 that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. FDA’s programs are national in scope and effect, and the agency’s activities have a direct and significant impact on multi-billion-dollar industries, in addition to protecting the health and safety of American Consumers. The work of the Agency is carried out by a staff of more than 18,000 scientists, physicians, regulatory and other personnel stationed throughout the United States.
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.
FDA Office of Oncological Disease (OOD) - What We Do
As oncologists and hematologists at the FDA, we engage researchers, patients, global regulators, and educators in a multifaceted approach to improve cancer care. Our commitment to public health, collaboration, and patient-centered regulatory decision-making drives our passion for advancing the availability of safe and effective drugs and biologics to patients with cancer. This manifests in the following six areas of activity.
We may spend up to eight hours weekly seeing patients in clinic to maintain our clinical skills. Area oncology centers include Johns Hopkins, Sibley Memorial Hospital, University of Maryland, George Washington University, Georgetown University, National Cancer Institute (NIH), Veterans Administration (VA), and Walter Reed National Military Medical Center.
At the FDA, we can further develop our career with pursuits in research or clinical care. Some of us continue to see patients for up to 8 hours a week in a variety of clinical settings such as precepting fellows, second-opinion clinics, continuity clinics, and inpatient medicine in academic, community, or government facilities. We also engage in many research activities, and we publish original research, review articles and commentaries, approval summaries for drugs we approve for marketing, and expert working group reports.
We are very active in research. An analysis of recent oncology scientific publications revealed that our papers are enriched for high-impact publications and have nearly two times the number of citations as an average NIH-funded paper. FDA oncology staff has contributed to numerous publications in scientific literature which can be found in PubMed including The New England Journal of MedicineExternal Link Disclaimer, Lancet Oncology, Nature Reviews Clinical OncologyExternal Link Disclaimer, Journal of Clinical OncologyExternal Link Disclaimer, JAMA Oncology, and more.
Description of Position
Medical officers at FDA perform duties for purposes such as:
- Ensuring all human drugs manufactured for interstate sale are safe and effective with truthful and informative product labeling
- Ensuring the safety, potency, purity and effectiveness of vaccines, blood products, certain diagnostic products and other biological and biotechnology-derived human products
- Ensuring the safety and effectiveness of medical devices and eliminating unnecessary human exposure to manmade radiation from medical, occupational and consumer products
- Conducting inspections and investigations of food and drug manufacturing establishments, performing analytical work and recommending enforcement actions.
Qualifications
MD or Do from a school in the US or Canada
US citizen or Green Card holder
Familiarity with the regulatory side of drug development
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