The following general positions represent some of the ongoing career opportunities available at CDER:

• Physicians. (Various medical specialties) Evaluate data involving the animal testing and human clinical trials of new drugs to determine their safety and effectiveness.

• Scientists. The following fields: Biology, Chemistry, Microbiology, Pharmacology, Pharmacokinetics, Toxicology, and Epidemiology. Scientists evaluate portions of Investigational New Drug Applications (INDs) and New Drug Applications (NDAs) that pertain to their particular discipline.

• Consumer Safety Officers (Project Managers). Perform management and liaison responsibilities in conducting records maintenance, monitoring the work effort and advising review team members on regulatory requirements, and coordinating information with pharmaceutical industry officials.

• Mathematical Statisticians. Provide statistical support to the drug review divisions.

• Computer Specialists. Provide ADP infrastructure, application and technology services to CDER in support of automated drug review, administrative, data storage/retrieval and training processes.

• Administrative/Technical/Clerical
The Center for Drug Evaluation and Research also has positions available in administrative, technical and clerical fields. These positions include, Administrative Officer, Consumer Safety Technician, Secretary, Clerk Typist, Management Analyst, Program Support Specialist, Program Specialist, Management Officer, Senior Management Officer, etc....... grades GS-3 through SES.

Physicians. (Various medical specialties) Evaluate data involving the animal testing and human clinical trials of new drugs to determine their safety and effectiveness. Basic qualification is a Doctor of Medicine or Doctor of Osteopathy. Graduates of foreign medical schools must be ECFMG certified. Board certification/eligibility in a medical specialty and experience in conducting clinical trials are highly desired for these positions. Physicians may also be paid an additional Physician Comparability Allowance up to $24,000 (depending on years of Federal experience). GS14-10-GS15-10

Scientists. Biology, Chemistry, Microbiology, Pharmacology, Pharmacokinetics, Toxicology, Epidemiology: Scientists evaluate portions of INDs/NDAs that pertain to their particular discipline. They determine the scientific validity of manufacturers’ tests, drug safety and efficacy claims. A doctorate degree in the scientific discipline with at least two years postdoctorate experience is highly desired for these positions. GS12-GS13

Consumer Safety Officers (Project Managers). Perform management and liaison responsibilities in conducting records maintenance, monitoring the work effort and advising review team members on regulatory requirements, and coordinating information with pharmaceutical industry officials. Qualifications: a degree or combination of courses in the fields of biological science, chemistry, pharmacy, physical science, food technology, nutrition, medical science, epidemiology, engineering, veterinary medical science, or related scientific fields. Project management experience in the health care/pharmaceutical industries is highly desired for these positions. GS5-GS13

Mathematical Statisticians. Provide statistical support to the drug review divisions. Employ a broad variety of statistical procedures relevant to the regulatory and scientific preclinical and clinical drug development and approval decision processes. A doctorate degree in mathematics/statistics and experience in the design, performance and evaluation of clinical trials or related biomedical or pharmacokinetics investigations are highly desired for these positions. GS11-GS13

Computer Specialists. Provide ADP infrastructure, application and technology services to CDER in support of automated drug review, administrative, data storage/retrieval and training processes. An undergraduate/graduate degree in computer science, information science, information systems management, mathematics, statistics, operations research, engineering, or course work that required the development and/or adaptation of computer programs and systems and provided knowledge equivalent to a major in the computer field, OR experience that demonstrated accomplishment of computer project assignments that required a wide range of knowledge and techniques pertinent to the position to be filled, such as experience in software development tools (Oracle Developer 2000, Oracle Designer 2000 and Java), server (DEC Alpha, WIN/NT, MS Windows), and web development tools. GS9-GS13