Career Opportunities at the Center for Drug Evaluation and Research (Videos)

From administrators to reviewers, investigators to scientists, and high school students to seasoned professionals, FDA’s Center for Drug Evaluation and Research has career opportunities for all. Take a look at the types of exciting activities happening at the Center, and see if working at CDER is the right fit for you. We hope to see you on the FDA campus soon!

What is FDA’s role in regulating drugs?

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You may know the FDA is responsible for approving new drugs and making sure those drugs are safe, high quality, and work the way they’re supposed to.

But HOW is it done? How are decisions made, and are those decisions in your best interest? What else does the FDA do--and NOT do?

These are important questions! And the FDA understands the importance of asking and answering questions -- because that’s exactly what it does.

The highly trained staff in the FDA’s Center for Drug Evaluation and Research are committed to protecting the public’s health, advancing science, and regulating human drugs.

These staff analyze data, evaluate research, and make decisions based on science to ensure that prescription, generic, biosimilars, and over-the-counter drugs work correctly. They use science and data to ask – and answer – questions like:

Is this new drug safe?
Does it work the way it’s supposed to?
Do the benefits of this drug outweigh the risks?

And once drugs are approved, the FDA monitors them for safety and quality for years to come.

This thorough analysis helps the FDA provide the timely information health care providers and patients need to choose treatments wisely.

The FDA’s decisions are not influenced by industry or politics. The FDA’s decisions are guided by science and data.

It’s important to know that the FDA oversees clinical trials for safety and reviews the resulting data. However, the FDA does NOT conduct clinical trials.

FDA also does NOT control the cost of drugs or get involved in interactions between patients and their health care providers.

As part of its public health mission, the scientists and staff at FDA work to protect the American public by getting the accurate, science-based information they need to use medications wisely. All by asking questions and letting science lead to the answers.

Questions about the FDA and human drugs? Find the answers at www.fda.gov/drugs.

How does the FDA approve new drugs?

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When you reach for your prescription medications, you trust that the medicine is going to do what it’s supposed to do – make you feel better!

That trust comes from knowing that teams of doctors, biologists, chemists, pharmacists and other health scientists at the FDA are working tirelessly to protect the health of the American public by making careful, informed decisions about which new drugs to approve.

So how does the FDA determine if a drug is safe and effective?

It follows a comprehensive, multistep process that includes many steps and check points.

First, a drug maker develops a drug to help treat a disease or medical problem, then they test it in a lab.

If these preliminary tests go well, the drug maker fills out an Investigational New Drug Application and submits it to the FDA. This application explains how the drug maker plans to investigate and test the drug in clinical trials on volunteers. These clinical trials, which can take about 6 years to complete, must follow a set of laws and regulations that are meant to protect the rights, safety, and welfare of volunteers.

There are typically three phases in a clinical trial, with each phase involving more patients. It’s important to remember that the FDA does NOT develop new therapies or conduct clinical trials; however, FDA DOES have rules to ensure they remain safe.

Once the drug maker has conducted the clinical trials and has gathered enough data to show the drug is safe and effective, they can submit a New Drug Application to get that drug approved by the FDA.

At this point, an unbiased team of FDA experts evaluates the clinical trial research and scientific data to determine if it meets FDA’s rigorous standards. The FDA asks questions like, is this drug safe? Does it work the way it should? Is it high-quality? Do its benefits outweigh its known risks?

If the answers are yes, the FDA then inspects the facility where the drug will be made to make sure it meets the FDA’s standards for manufacturing.

If the FDA team determines that the research, data, and evidence shows that the drug is safe and effective for the intended use, the FDA approves the drug.

Once a drug is approved and patients begin taking it, the FDA continues to monitor the drug’s safety, effectiveness, and quality for years to come.

The process to develop and then approve a medication can take several years; it’s a sign that the FDA is committed to protecting patients. So, the next time you pick up that prescription medication, you can trust that it’ll do what you need it to do, safely and effectively.

Questions about the FDA or the clinical trials? Learn more at www.fda.gov/drugs.

What does the FDA do after drugs are approved?

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When you fill a prescription from your doctor, you trust that it will be safe and effective. That trust comes from knowing that teams of doctors, biologists, chemists, pharmacists, and other health scientists at the FDA made informed decisions about which drugs to approve, based on science and data.

But what happens after drugs are approved? HOW does the FDA continue to monitor them for years to come, and WHY is this so important?

The FDA conducts a thorough analysis to ensure that prescription drugs are ONLY approved after three phases of clinical trials have shown they are high-quality, safe, and work as they should. These trials can involve hundreds, or sometimes thousands, of people.

But once the drug is on the market and available to patients for use, new data about safety and effectiveness can come to light. The FDA keeps track of that new data, which can come from patients, drug makers, or health care professionals, and may include information about negative reactions to prescriptions.

Based on this information, the FDA may recommend that the drug maker update the drug labeling by adding warnings or updated dosage information. Changes could also include the FDA requesting a drug recall, but the need for that is rare.

The FDA also conducts ongoing inspections of facilities where drugs are made to make sure that drug companies are following quality and safety standards.

The FDA keeps track of all this drug data and makes sure the public stays informed. You can find information about drug recalls through your health care providers and other trusted sources of health information, such as FDA’s MedWatch page, where patients can also report safety concerns.

All of these safety measures—including requesting recalls from companies—are a sign that the FDA is doing its job. By closely monitoring drugs in development, at approval, and years after, the FDA looks out for you, by ensuring that the medicines you rely on are safe and effective.

Questions about the FDA? Find the answers at www.fda.gov/drugs.

Many just need an opportunity. Join FDA’s Center for Drug Evaluation and Research (CDER)

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Planning out your career goals or searching for opportunities? Let’s explore your options at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, also known as CDER.

Whether you’re a graduate biomedical student seeking experience; a postgraduate looking for fellowships; or a senior scientist pursuing a research career, CDER offers many paths into the fascinating field of regulatory science.

Before I tell you more about available programs and fellowships, let me tell you about CDER.

FDA’s largest Center, CDER has built a simple and strong foundation: make sure safe and effective drug products are available to improve the health of people in the United States. CDER has almost 4,500 employees; 80 percent fall into scientific fields. At CDER, you can touch many aspects of drug development, review, and the approval process.

Still interested? Great! Let’s talk about how you can join CDER.

Want to get your foot in the door? Check out these CDER programs.

The Pathways program provides career development for those who have graduated college in the past two years. And for those who have earned a graduate degree, Pathways has the Presidential Management Fellowship.

CDER’s Oak Ridge Institute for Science and Education gives recent grads and university teachers educational experience and training in public health and science.

The Regulatory Science Student internship program provides internships to graduate students. During your time at CDER, you gain professional experience and can explore other options.

The Visiting Pediatric Pharmacology Fellows Rotation Program gives pediatric pharmacology fellows in established academic programs a chance to rotate within various review teams in CDER. You will learn about pediatric drug development and regulatory principles

The Commissioner’s Fellowship program offers two-year fellowships in regulatory science training and research to those with a Doctoral-level degree or individuals with a Bachelor’s or Master’s degree in an engineering discipline.

Finally, the Service Fellowship Plan provides temporary employment, training and professional development to promising research and regulatory scientists -- for up to five years!

Applicants to the Service Fellowship plan must have a Ph.D. or equivalent doctoral degree in an eligible science program. However, a lower level of education and experience may be fine depending on program need.

You are part of a valuable pool of talent that can help CDER deal with complex and exciting possibilities. Take advantage of opportunities at CDER to start or enhance your career!

Remember, you miss 100 percent of the shots you don’t take. So, don’t miss your shot at a great career!
Don’t miss
Don’t miss
Don’t miss
Don’t miss
Don’t miss
Don’t miss
Don’t miss your opportunity!

For more information about FDA’s Center for Drug Evaluation and Research visit f-d-a dot g-o-v slash drugs.
For more information about available fellowships visit f-d-a dot g-o-v and search - Fellowship

Looking for the best and the brightest to join FDA’s Center for Drug Evaluation and Research

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Are you smart, talented, ambitious, already at the top of your field or have the potential to be?

Learn what 4,500 people already know: how satisfying it is to work for the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research. FDA’s Center for Drug Evaluation and Research is a rich resource of health care expertise and regulatory experience.

Many have discovered that it’s a rewarding place to work because of its mission to protect the public health, collaborative environment, and the breadth of products and review areas.

CDER is looking for people that have a science focus, are analytical, thrive in collaborative work environments, and have a desire to impact many lives.

While the work in the center is complex, the premise is simple: ensure drugs are reviewed for safety, effectiveness and quality to improve the health of people in the United States.

You will be part of the decision-making process and can work on a variety of different drug products, as well as all aspects of drug discovery, development, approval, and marketing.

Give us the opportunity and we’ll give you a career.

Working at FDA’s Center for Drug Evaluation and Research can give you experience with regulatory issues, diverse methodologies, clinical trial designs, observational studies and drug indications.

Collaborate with other highly-trained professionals.

Engage in research.

Participate in professional societies and associations.

Create outreach materials designed for consumers, such as videos, brochures, campaigns and peer-reviewed publications.

Once in, you’ll be able to take advantage of other opportunities and multiple areas of interest.

You will experience opportunities for growth and networking all while earning a good living.

And like every federal government office, we offer paid vacations, ten paid holidays, health care savings and insurance plans, and a federal pension.

Other special benefits include flexible workplace and work hours, training, on-site child care, and an on-campus workout facility.

To join CDER, go to usajobs.gov and search FDA/CDER to see a list of available openings and required qualifications.

The frontiers of clinical pharmacology and drug development

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Hi - I’m Sarah, a clinical pharmacologist in the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, also known as CDER. Are you like me and enjoy challenging the boundaries of clinical pharmacology, and working in a dynamic, collaborative, interdisciplinary environment that fosters innovative thinking?

When I discovered that the frontiers of clinical pharmacology and drug development research intersect at the FDA and CDER, I was hooked and knew that CDER was the right place for me!

CDER employs talented clinicians and biomedical scientists from diverse backgrounds. They engage in research and work with outside experts to remain on the cutting edge of their field. We are alsways looking for talented pharmacologists. Our goal is to improve the current drug development and review paradigm in order to assure regulatory policy and decision making are based on the best available science.

Our scientists already know how rewarding it is to combine public service with a career. We’d like you to join us and see what it’s all about. You will be part of the team reviewing new drugs.

You will increase your knowledge of regulatory precedence, clinical trial designs, pharmacometrics, pharmacogenomics, and systems pharmacology…the work is quite multi-dimensional.

You will have a hand in many aspects of drug discovery, development, and approval.

You will work with chemists, physicians, and other health care professionals on a variety of drug products on a daily basis.

There are opportunities for you to specialize in therapeutic areas from hematology/oncology -- which is where I work -- to infectious disease, dermatology, cardio-renal, neuro-psych, rheumatology, pediatrics, and more—the choice is up to you!

CDER offers a competitive salary package, a comprehensive benefit plan on par with the private sector, AND a retirement plan which includes a federal pension.

As an employee at CDER, you’ll have opportunities for promotions, networking, career development, and temporary assignments in other CDER offices or even different Centers within FDA.

And once you’re in the federal government the opportunities are endless. And let’s not forget that there’s room to advance. It’s all here in a stable career environment, while you enjoy a great quality of life.

Give us a chance and we’ll provide you with the opportunity for a fantastic career. Coordinate with other highly-trained clinical pharmacology regulatory scientists. Coordinate with other highly-trained clinical pharmacology regulatory scientists.

Take advantage of research projects which are supported through research grants, and publishing opportunities.

CDER is a rich and rewarding environment to sharpen your clinical pharmacology expertise and boost your regulatory experience. More than 185 of your fellow clinical pharmacologists have discovered that CDER is a unique place to work because of its mission to the public health.

Like I said, coming to work for CDER was the right decision for me. And once you’ve analyzed the data, I’m sure you will agree that working for CDER is the right decision for you!

VO: To join CDER, go to usajobs.gov and search F-D-A/C-D-E-R to see a list of available openings and required qualifications.

Division of Applied Regulatory Science in FDA’s Center for Drug Evaluation and Research

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The U.S. Food and Drug Administration is looking for scientists that use computers as their laboratories.

Computational scientists at FDA’s Center for Drug Evaluation and Research deliver solutions in bioinformatics, instrumentations, systems pharmacology, and systems engineering, all designed to meet the Center’s unique scientific computing needs.

If you understood what I just said you are exactly the type of person we are looking for!

While the work at FDA’s Center for Drug Evaluation and Research is complex, the premise is simple: ensure that safe and effective drug products are available to improve the health and treatment of people in the United States.

I came to FDA because I wanted to participate in research that had a clear and immediate impact on improving human health.

As a laboratory researcher in the Center, I have the opportunity to change the way drugs are developed, and to improve the current methods for evaluating drug safety.

I generate data that explains why different patients respond differently to the same drug. I also research ways to improve the early assessment of drug safety to cut down on drug development.

My current research involves figuring out how information regarding the electrical behavior of cells in the lab can be used to predict the risk of serious side effects in people.

In addition to lab work, I am part of a broad effort to develop new biomarkers as drug development tools for use in toxicology testing.

I also use cutting edge technology in my laboratory research. To support our cardiac safety research efforts we have the latest generation of automated patch clamp machines. We also have access to other game-changing research technologies, including next generation sequencing, mass spectrometry, and digital pathology.

Although, technology evolves so fast, what I’m working with today could be outdated before we finish filming! No to worry, when necessary the Center will replace it with the latest and greatest.

Let’s see… important research with a clear impact on human health; a rich scientific environment; and new technologies that you can use.

What else could you want? What if we throw in a nice work-life balance, including flexible hours and the possibility of telework?

And it even pays well -- a package that includes a good salary, great benefits, and job security. Now this is the type of package that allows scientists to focus on doing good research rather than financial drama.

Be a part of FDA’s Center for Drug Evaluation and Research.

I know coming to FDA was the right decision for me. Do your math and do your research to see if it’s the right place for you too.

To join CDER, go to usajobs.gov and search F-D-A/C-D-E-R to see a list of available openings and required qualifications. For more information about FDA’s Center for Drug Evaluation and Research, go to FDA.gov.

Inspector-Reviewers: Bridging the past and Future

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In 1913, The Civil Service Magazine stated that the duty of an inspector in the U.S. Food and Drug Administration is to:

“Inspectors assist in the enforcement of the Food and Drugs Act of 1906 by collecting samples of products for analysis, collecting evidence of the shipment of such products, and paving the way to successfully prosecute violations..”

More than 100 years later, inspectors-reviewers in FDA’s Center for Drug Evaluation and Research, known as CDER, are still uncovering problems, righting wrongs, and ensuring drug products are developed and manufactured based on good science and design.

And there is still a need for high-quality inspector-reviewers. CDER is looking for scientists that

are analytical,
thrive in collaborative work environments, and
have a desire to impact many lives.

In CDER, the Bioequivalence and Good Laboratory Practice inspection programs need expert scientists to inspect bioanalytical and non-clinical labs. These inspector-reviewers evaluate sites, conducting clinical and non-clinical studies. They review inspection findings to determine any possible impact on new drugs, generic drugs, and biologics.

“There is no doubt that our country has a considerable number of ambitious men and women who can help improve the development of drug products and promote the health of their fellow Americans.”

CDER directs and reviews inspections of

CDER inspector-reviewers specifically participate in the inspection of:

sites that conduct bioanalysis of samples from subjects participating in clinical studies and;
non-clinical laboratories that follow the Good Laboratory Practices regulations.

Basic qualifications require at least a bachelor’s degree with 30 semester hours or experience in areas like biological sciences, chemistry, pharmacy, and medicine. Advanced degrees with knowledge and hands-on experience with bioanalytical techniques of both small and large molecules is also desired. Coursework or experience in computer programming and statistics helps…

…so does a willingness to relocate to the Washington, D.C. area.

Once hired, there are opportunities to travel throughout the United States and around the world.

While the qualifications set a high bar, those that meet the requirements can guarantee themselves a rewarding career.

“The experience and training of an inspector is a valuable course in the university of life. And the degree conferred by this university spells S-U-C-C-E-S-S."

Do your research and learn what CDER’s inspector-reviewers already know: how satisfying it is to work for the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research.

To join FDA’s Center for Drug Evaluation and Research, go to usajobs.gov and search F-D-A/C-D-E-R to see a list of available openings and required qualifications.

Why it’s cool to be a statistician at FDA

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Are you smart, talented, ambitious and know your way around data? Take a calculated risk and join the Federal government.

Examine what more than 190 statisticians already know: how satisfying it is to work at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, also known as CDER.

While the work at CDER is complex, the premise is simple: you make sure that safe and effective drug and biological products are available to improve the health of people in the United States.

Statisticians are essential in the drug and biologics development and review processes because they ensure the validity and accuracy of findings at all stages. This type of work is indispensable for protecting public health.

Like all federal government agencies, CDER offers vacation time, health care, ten paid holidays, retirement savings and insurance plans. Other special benefits include flexible workplace arrangements, training, on-site child care, and an on-campus workout facility.

Give us the opportunity and we’ll help take your career to the next level. FDA’s Center for Drug Evaluation and Research is a rich resource of statistical expertise and regulatory experience.

More than 190 of your fellow statisticians have discovered that it’s a unique place to work because of its mission to the public health, collaborative environment, and the breadth of products and review areas.

Run the numbers, analyze the data and see how working for CDER could be the right decision for you.

To join CDER, go to usajobs.gov and search FDA/CDER to see a list of available openings and required qualifications.

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