Medical Officer/Safety Reviewer

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

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). 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. 

FURTHER INFORMATION

All questions regarding the position, benefits, and salary may be directed to the OND Recruitment Team at: ond-employment@fda.hhs.gov; or: 301-796-0800. To apply, please submit a cover letter and CV/resume to: ond-employment@fda.hhs.gov. Please indicate that you are applying to source code #017-016SR.