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Dermatologist

Company: FDA Office of New Drugs
Location: Silver Spring
Posted on: March 28, 2020

Job Description:

Dermatologist Are you making a difference contributing to the public health and well-being of millions of Americans Would you like to The physicians, scientists and other dedicated professionals at the U.S. Food & Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) located in Silver Spring, MD, contribute to the public health of millions of Americans every day. We pride ourselves on our dedicated and skilled staff and are always looking for committed individuals to help us achieve our mission. OND's public health mission is to protect and enhance the health of the public through the review and evaluation of scientific data submitted by pharmaceutical manufacturers in support of Investigational New Drug applications (IND) to administer investigational products in clinical trials and in support of New Drug and Biologic Licensing applications (NDA/BLA) to determine if candidate products are safe and effective. The Division of Dermatology and Dentistry (DDD) within the Office of Immunology and Inflammation (OII) is seeking highly qualified dermatologists to serve as clinical reviewers. The clinical reviewer is responsible for determining whether clinical trials of new drugs or biologics related to dermatologic conditions in humans are soundly conceived and supported by prior animal testing and other controls adequate to justify tests in humans. They review applications by manufacturers for permission to market new drugs and biologics for general use and make recommendations based on an evaluation of the evidence of their safety and effectiveness; they ensure proposed labeling contains truthful claims for safety and effectiveness, and adequate directions for use and warnings against misuse. The clinical reviewer also reviews supplements and amendments to previously approved NDAs/BLAs; periodic reports submitted by sponsors on drugs approved for marketing; and adverse reactions and other safety reports. They make medical decisions as to whether the indicated population of a previously approved NDA/BLA should be expanded, determine whether changes in the labeling are required, and whether the information available supports approval of the supplement. They review summaries of pharmacologists, toxicologists, statisticians, and chemists as part of the decision-making process. They make science-based recommendations that an NDA/BLA or a supplement submission be approved, is incomplete on specific points, or be disapproved. As a clinical reviewer, you will have the opportunity to: Advance the public health through new drug development;Experience teaching and training opportunities;Interact with pharmaceutical companies; andWork with a wide range of scientific disciplines in a team-oriented atmosphere. SALARY & BENEFITS Civil service salary starting at the GP-14 levelExcellent federal government benefits package (health insurance, life insurance, retirement, etc.).Relocation expenses and student loan repayment may be paid to eligible candidates.Flexible and/or partial telework schedules available (after completion of initial training period). QUALIFICATIONS Applicants must have a Doctor of Medicine or Doctor of Osteopathy degree from an accredited medical school. Graduates of foreign medical schools must be certified by the Education Commission for Foreign Medical Graduates (ECFMG). Candidates must be U.S. citizens. Permanent U.S. residents may apply for staff fellowship appointments. Excellent oral and written communication skills and an ability to work effectively on a team are necessary to be successful in this role. Prior human subject research experience and experience working with clinical data with knowledge and understanding of clinical trial design and product development programs are desirable, but not required. Certification by or eligibility for the American Board of Dermatology (ABD) is required. FDA IS AN EQUAL OPPORTUNITY EMPLOYER WITH A SMOKE FREE ENVIRONMENT Dermatologist Are you making a difference contributing to the public health and well-being ...

Keywords: FDA Office of New Drugs, Silver Spring , Dermatologist, Healthcare , Silver Spring, Maryland

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