Work for the FDA's Center for Drug Evaluation and Research (CDER)
What do Pharmacists do at CDER?
The duties of a Pharmacist at CDER differ by office. Opportunities may include:
- Providing advisory, regulatory, scientific, and clinical guidance for information related to drugs, new drug approvals, and the applicable laws and regulations that may include reviewer, clinical analyst, and/or project management roles.
- Participating in meetings with regulated industry and Office, Center, and Agency officials on scientific and practical issues related to medical product applications. Exchanging ideas with other scientists and developing background data pertinent to assigned programs.
- Presenting investigative results at scientific conferences and in journal submissions.
- Operating and maintaining FDA’s publication on the assessment of new and abbreviated new drug application-specific submission data for drug product listings and certain marketing protections.
- Processing and evaluating adverse event and medication error reports for drugs and therapeutic biologics. Developing and implementing procedures for post-marketing surveillance of drugs and therapeutic biologics to identify emerging safety signals.
- Providing risk management expertise on the design, development, and implementation of programs and initiatives to support CDER’s policies related to Risk Evaluation and Mitigation Strategies authorities.
- 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.
- Responding to inquiries on human drug matters from Congress, the public, media, and public interest groups. Communicating with regulated industry as appropriate and recommending and developing public communications.
- Developing, coordinating, and ensuring documents, correspondence, and policies are sufficiently finalized for review and approval.
Related positions include:
How can I find a Pharmacist 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: 0660 - Pharmacist.
- 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.
