Non-Clinical Reviewer

Location
Silver Spring, MD
Salary
Salary Range: $99,000-$139,000 per year + benefits
Posted
September 17 2019
Ref
20-032EG
Position Type
Full Time
Organization Type
Govt.

Non-Clinical Reviewer

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.

CDER is responsible for regulating prescription drugs, including new drugs, generic drugs, biological products and biosimilars as well as over-the-counter drugs. CDER’s drug regulatory responsibilities include premarket review of new drugs and generic drugs; maintenance of the OTC drug monograph system; monitoring of all marketed drug safety and promotional activities; review, monitoring and enforcement of drug quality during the entire drug life cycle; and ensuring drug products in the market comply with the law. 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 manufactures in support of New Drug and Investigational New Drug applications (NDA/IND), and to determine if candidate drugs are safe and effective. OND is seeking scientists to serve as nonclinical reviewer’s in various drug review divisions.

The nonclinical reviewer is responsible for reviewing and evaluating the results of nonclinical pharmacologic, toxicologic, and pharmacokinetic studies submitted in support of INDs, NDAs, and BLAs; these studies assess drug safety based on studies conducted by the drug developer. Review of the nonclinical pharmacologic and toxicologic data includes evaluation of the quality and adequacy of the various assessments and studies. These reviews serve as the basis for calculating initial safe starting doses in clinical trials, doses for longer duration clinical trials, and for product labeling (the package insert). Nonclinical reviewers prepare a comprehensive review of the data and submit recommendations and conclusions for consideration of the review team. As a nonclinical reviewer, you will have the opportunity to:

  • Advance the public health through new drug development;
  • Experience teaching and training opportunities;
  • Interact with pharmaceutical companies; and
  • Work with a wide range of scientific disciplines in a team-oriented atmosphere.

SALARY & BENEFITS

  • Civil service salary at the GS-13 level
  • Excellent 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 doctorate degree in pharmacology, toxicology, or a related field from an accredited university. Foreign graduates must have their transcripts and degrees evaluated by a credential evaluation service that is recognized by the National Association of Credential Evaluation Services (NACES) or the Association of International Credentials Evaluators (AICE). Candidates must be U.S. citizens. Permanent U.S. residents may apply for staff fellowship appointments.

TO APPLY

Please send a current CV/resume and cover letter to ond-employment@fda.hhs.gov for consideration. Please reference source code: #20-032EG in the subject line.

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