Computer Operator II
Rockville, MD ยท On-site
Ivyhill has an immediate need for a Computer Operator II that will support our their FDA CDER DCC project in Rockville, MD. The Computer Operator II (CO2) will process scheduled routines that present ...
Rockville, MD ยท On-site
Ivyhill has an immediate need for a Computer Operator II that will support our their FDA CDER DCC project in Rockville, MD. The Computer Operator II (CO2) will process scheduled routines that present ...
Rockville, MD ยท On-site
Ivyhill has an immediate need for a Computer Operator II that will support our their FDA CDER DCC project in Rockville, MD. The Computer Operator II (CO2) will process scheduled routines that present ...
Ivyhill has an immediate need for a Computer Operator II that will support our their FDA CDER DCC project in Rockville, MD. The Computer Operator II (CO2) will process scheduled routines that present ...
Ivyhill has an immediate need for a Computer Operator II that will support our their FDA CDER DCC project in Rockville, MD. The Computer Operator II (CO2) will process scheduled routines that present ...
Rockville, MD ยท On-site
Ivyhill has an immediate need for a Computer Operator II that will support our their FDA CDER DCC project in Rockville, MD. The Computer Operator II (CO2) will process scheduled routines that present ...
Quick apply
Rockville, MD ยท On-site
Ivyhill has an immediate need for a Computer Operator II that will support our their FDA CDER DCC project in Rockville, MD. The Computer Operator II (CO2) will process scheduled routines that present ...
Silver Spring, MD ยท On-site
$100K - $135K/yr
Collaborate with CDER OND staff to optimize team processes and deliverables. * Work with FDA ... stakeholders to review background packages and mock safety datasets to assess appropriateness of ...
Silver Spring, MD ยท On-site
$100K - $135K/yr
Collaborate with CDER OND staff to optimize team processes and deliverables. * Work with FDA ... stakeholders to review background packages and mock safety datasets to assess appropriateness of ...
Silver Spring, MD ยท On-site
$90K - $120K/yr
Collaborate with CDER OND staff to optimize team processes and deliverables. * Work with FDA ... stakeholders to review background packages and mock safety datasets to assess appropriateness of ...
Quick apply
Silver Spring, MD ยท On-site
$90K - $120K/yr
Collaborate with CDER OND staff to optimize team processes and deliverables. * Work with FDA ... stakeholders to review background packages and mock safety datasets to assess appropriateness of ...
Rockville, MD ยท On-site
U.S. Food and Drug Administration, FDA CDER Employment Type: Full-Time Status: Contingent upon contract award Position Overview NeevSys is seeking an experienced Help Desk Manager to lead Tier 0 ...
New
Rockville, MD ยท On-site
U.S. Food and Drug Administration, FDA CDER Employment Type: Full-Time Status: Contingent upon contract award Position Overview NeevSys is seeking an experienced Help Desk Manager to lead Tier 0 ...
New
Silver Spring, MD ยท On-site
$90K - $120K/yr
Collaborate with CDER OND staff to optimize team processes and deliverables. * Work with FDA ... stakeholders to review background packages and mock safety datasets to assess appropriateness of ...
Silver Spring, MD ยท On-site
$90K - $120K/yr
Collaborate with CDER OND staff to optimize team processes and deliverables. * Work with FDA ... stakeholders to review background packages and mock safety datasets to assess appropriateness of ...
Rockville, MD ยท On-site
Familiarity with ISO 17025 laboratory accreditation requirements and FDA CDER or OPQR laboratory environments is a plus. Experience with FIPS 140-compliant encryption standards, Section 508 ...
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Rockville, MD ยท On-site
Familiarity with ISO 17025 laboratory accreditation requirements and FDA CDER or OPQR laboratory environments is a plus. Experience with FIPS 140-compliant encryption standards, Section 508 ...
Silver Spring, MD ยท On-site
$100K - $135K/yr
Collaborate with CDER OND staff to optimize team processes and deliverables. * Work with FDA ... stakeholders to review background packages and mock safety datasets to assess appropriateness of ...
Quick apply
Silver Spring, MD ยท On-site
$100K - $135K/yr
Collaborate with CDER OND staff to optimize team processes and deliverables. * Work with FDA ... stakeholders to review background packages and mock safety datasets to assess appropriateness of ...
Washington, DC ยท On-site +1
... by FDA CDER or CBER, such as drugs, biologics, or advanced therapies * Experience with Bayesian, frequentist, and empirical methods * Experience supporting and advising government leadership or ...
New
Washington, DC ยท On-site +1
... by FDA CDER or CBER, such as drugs, biologics, or advanced therapies * Experience with Bayesian, frequentist, and empirical methods * Experience supporting and advising government leadership or ...
New
Washington, DC ยท On-site +1
... by FDA CDER or CBER, such as drugs, biologics, or advanced therapies * Experience with Bayesian, frequentist, and empirical methods * Experience supporting and advising government leadership or ...
New
Washington, DC ยท On-site +1
... by FDA CDER or CBER, such as drugs, biologics, or advanced therapies * Experience with Bayesian, frequentist, and empirical methods * Experience supporting and advising government leadership or ...
New
Silver Spring, MD ยท On-site +1
$213K - $340K/yr
Coordinates with FDA offices to provide timely safety information to healthcare professionals and the public. * Represents OSE on CDER workgroups addressing clinical, regulatory, postmarket safety ...
Silver Spring, MD ยท On-site +1
$213K - $340K/yr
Coordinates with FDA offices to provide timely safety information to healthcare professionals and the public. * Represents OSE on CDER workgroups addressing clinical, regulatory, postmarket safety ...
Silver Spring, MD ยท On-site +1
$235K - $340K/yr
Coordinates with FDA offices to provide timely safety information to healthcare professionals and the public. * Represents OSE on CDER workgroups addressing clinical, regulatory, postmarket safety ...
Silver Spring, MD ยท On-site +1
$235K - $340K/yr
Coordinates with FDA offices to provide timely safety information to healthcare professionals and the public. * Represents OSE on CDER workgroups addressing clinical, regulatory, postmarket safety ...
FDA drug approval pathways * Generic drug regulations * CDER review processes * cGMP requirements * CMC regulatory requirements * Drug Master Files * Quality Systems * Experience supporting ...
New
FDA drug approval pathways * Generic drug regulations * CDER review processes * cGMP requirements * CMC regulatory requirements * Drug Master Files * Quality Systems * Experience supporting ...
New
FDA drug approval pathways * Generic drug regulations * CDER review processes * cGMP requirements * CMC regulatory requirements * Drug Master Files * Quality Systems * Experience supporting ...
FDA drug approval pathways * Generic drug regulations * CDER review processes * cGMP requirements * CMC regulatory requirements * Drug Master Files * Quality Systems * Experience supporting ...
FDA drug approval pathways * Generic drug regulations * CDER review processes * cGMP requirements * CMC regulatory requirements * Drug Master Files * Quality Systems * Experience supporting ...
New
Quick apply
FDA drug approval pathways * Generic drug regulations * CDER review processes * cGMP requirements * CMC regulatory requirements * Drug Master Files * Quality Systems * Experience supporting ...
New
Silver Spring, MD ยท On-site +1
$121K - $191K/yr
... of FDA regulations. * Petitions responses and conducts thorough analyses of complex regulatory and policy issues and provides advice to staff in CDER in carrying out its regulatory mission.
Silver Spring, MD ยท On-site +1
$121K - $191K/yr
... of FDA regulations. * Petitions responses and conducts thorough analyses of complex regulatory and policy issues and provides advice to staff in CDER in carrying out its regulatory mission.
$35.7K - $44.4K
2% of jobs
$44.4K - $53.1K
10% of jobs
$53.1K - $61.7K
9% of jobs
$64.4K is the 25th percentile. Wages below this are outliers.
$61.7K - $70.4K
16% of jobs
The median wage is $77.1K / yr.
$70.4K - $79.1K
18% of jobs
$79.1K - $87.8K
17% of jobs
$90.6K is the 75th percentile. Wages above this are outliers.
$87.8K - $96.5K
12% of jobs
$96.5K - $105.2K
7% of jobs
$105.2K - $113.9K
4% of jobs
$113.9K - $122.6K
3% of jobs
$122.6K - $131.3K
2% of jobs
$35.7K
$81.1K
$131.3K
An FDA CDER job refers to a role within the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). CDER is responsible for ensuring the safety, effectiveness, and quality of human drugs. Jobs in CDER can include roles in drug review, regulatory science, pharmacology, and policy development. Employees work to evaluate new drug applications, monitor post-market drug safety, and develop guidelines to improve public health. Positions may require expertise in medicine, pharmacy, biology, chemistry, or regulatory affairs.
To thrive in a role within the FDA's Center for Drug Evaluation and Research (CDER), you typically need a background in pharmaceutical sciences, regulatory affairs, medicine, or related scientific fields, often with an advanced degree such as a PharmD, PhD, or MD. Familiarity with regulatory guidelines (e.g., FDA, ICH), submission management systems, and data analysis tools is commonly required, along with certifications like RAC (Regulatory Affairs Certification) being beneficial. Exceptional analytical thinking, attention to detail, and effective written and verbal communication skills help professionals excel in multidisciplinary team settings. These competencies are essential for ensuring thorough drug evaluation, compliance with regulations, and safeguarding public health.
At FDA CDER, typical daily responsibilities include reviewing data from drug development and clinical trials, preparing and assessing regulatory submissions, and collaborating closely with colleagues across scientific, legal, and public health disciplines. Professionals may participate in meetings to discuss safety or efficacy issues, draft guidance documents, and respond to inquiries from pharmaceutical companies. Teamwork and cross-disciplinary communication are frequent given the complexity of regulatory decisions. The work is highly detail-oriented and focuses on ensuring that medications are safe and effective for public use.

Full-time
Medical, Dental, Vision, Life, Retirement
Re-posted 22 days ago
Sourced by ZipRecruiter
11 - 50 Employees
College Park, MD, US
2015