The Division of Neurology Products in the Office of New Drugs at the U.S. Food and Drug Administration is actively recruiting physicians to serve in our dynamic, highly challenging and innovative atmosphere at the intersection of law, medicine, and science. Medical Officers are the cornerstone of FDA's public health mission to ensure the safety and efficacy of drug products. Positions on the safety team in the Division of Neurology Products offer the opportunity to evaluate the safety of drug products during the approval process and through the lifetime of the product and to provide scientific and regulatory guidance to industry and academicians through the evaluation of both clinical trial data submitted for product approval and postmarketing information. Successful candidates work as part of a multidisciplinary review team in a collegial environment, and are provided with many opportunities for new employee training through the FDA and through professional meetings. Medical Officers may also take advantage of weekly professional development time in order to maintain clinical skills.
SUMMARY OF DUTIES
Reviews and evaluates clinical safety data related to marketing applications for new drugs and biologics and recommends whether safety of the products has been established
Reviews and evaluates new clinical safety data related to approved products to evaluate safety of drugs and biologics on an ongoing basis
Reviews proposed drug labels to determine whether they contain truthful claims for safety and adequate directions for use and warnings against misuse
Interacts with the regulated industry in official meetings during the review of marketing applications and in the postmarketing period
Serves as the medical expert on a multidisciplinary team to determine whether a clinical trial or study and/or risk evaluation and mitigation strategy (REMS) will address specific safety issues in the postmarketing setting.
SALARY & BENEFITS
Civil service base salary at the GS-14 level, plus a generous supplemental allowance determined by relevant experience, medical specialty, and board certification
Excellent Federal Government benefits package (health insurance, life insurance, thrift savings plan, retirement, etc.)
Student loan repayment available for eligible candidates.
Flexible work schedules
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). Applicants must have a permanent, full, and unrestricted license to practice medicine in a State, District of Columbia, or a territory of the United States. Candidates for Civil Service or U.S. Commissioned Corps must be U.S. citizens. Permanent U.S. residents may apply for staff fellowship appointments.
Candidates must have completed a residency and have a strong background in internal medicine.
All questions regarding the position, benefits, and salary may be directed to the OND Recruitment Team at: email@example.com; or: 301-796-0800. To apply, please submit a cover letter and CV/resume to: firstname.lastname@example.org. Please indicate that you are applying to source code #017-018SR.
The Center for Drug Evaluation & Research (CDER) at the Food and Drug Administration (FDA) carries out an essential public health mission by ensuring that safe and effective drugs are available to improve the health of the American people. The Office of New Drugs in CDER is the nexus where this oversight of drug development and review takes place. We advance public health by helping to bring new p...roduct innovations to market. Our work begins when pharmaceutical manufacturers prepare to begin clinical testing of their new products. We ensure the safety of patients in clinical trials and provide advice to manufacturers on the design and conduct of the trial and the analysis of the trial results. Our work continues when development of the product is complete and the manufacturer seeks approval to market the product. We evaluate and analyze the evidence of the drug’s safety and effectiveness to determine whether the new product meets FDA’s standards for approval. As part of this review, we also play a critical role in ensuring that healthcare professionals and patients have accurate science-based information so that new drugs are used safely and appropriately. Following approval, we continue to monitor marketed products to ensure their continued safety as they are used in a broader patient population.Our work in OND impacts the lives of Americans on a daily basis. We rely on experienced physicians and other highly qualified and dedicated professionals to carry out our important mission. OND operates in a team-based, collegial environment where our staff interacts with various scientific disciplines (e.g., statistics, clinical pharmacology, chemistry) that are all involved in drug regulation. Many opportunities also exist to provide scientific leadership through collaborative work with the pharmaceutical industry, academia, and other domestic and foreign regulatory agencies and other organizations. With the increasingly rapid development of new therapies that improve the lives of patients here and abroad, this is an exciting time to be part of the drug development and review enterprise.