What do General Health Scientists do at CDER?

The duties of a General Health Scientist at CDER differ by office. Opportunities may include:

• Engaging in the multidisciplinary evaluation of the safety, efficacy, and substitutability of drugs consumed by the American people.
• Reviewing abbreviated new drug applications and other types of submissions to support drug development and lifecycle issues that may relate to safety, efficacy, and substitutability of drug products.
• Evaluating drug safety programs by applying the principles, concepts, tools, and methodology related to program evaluation, implementation, and analysis.
• Compiling data to prepare and present briefings, presentations, and technical or scientific reports that convey relevant scientific data or clinical information to inform regulatory recommendations.
• Conducting drug safety surveillance on adverse event and medication error reports to identify emerging safety signals and mitigation strategies.
• Reviewing proposed proprietary medication names, labels/labeling, packaging, and human factor studies to identify, evaluate, and minimize the potential for medication errors for CDER-regulated products.
• Applying expert knowledge and analytical expertise to identify solutions for controversial data interpretation between industry applicants and the review divisions within the FDA.

Related positions include:

How can I find a General Health Scientist position at CDER?

Available CDER positions are listed on USAJOBS and under the FDA 21st Century Cures Act Hiring Authority.

• Search USAJOBS by Keyword: CDER. You can filter your search by Agency: Food and Drug Administration and Series: 0601 - General Health Science.
• Visit We Are Hiring | FDA to find a current listing of opportunities utilizing the FDA 21st Century Cures Act Hiring Authority.

Where can I learn more about careers at the FDA?

For general information on working at the FDA and additional employment opportunities, visit: Jobs and Training at FDA.