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Bizzell

Accompany an FDA-commissioned inspector to designated retail locations to assess compliance with tobacco sales regulations. * Attempt to purchase tobacco products while strictly adhering to FDA ...

Bizzell Group

Accompany an FDA-commissioned inspector to designated retail locations to assess compliance with tobacco sales regulations. * Attempt to purchase tobacco products while strictly adhering to FDA ...

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How much do fda jobs pay per hour?

As of Jun 15, 2026, the average hourly pay for fda in the United States is $39.35, according to ZipRecruiter salary data. Most workers in this role earn between $24.52 and $49.04 per hour, depending on experience, location, and employer.

Why is the FDA understaffed?

The FDA often faces staffing shortages due to limited budgets, increasing workload from expanding regulatory responsibilities, and lengthy hiring processes. These factors can delay the recruitment and retention of qualified personnel, impacting the agency's ability to efficiently oversee food, drugs, and medical devices.

Is it hard to get hired by the FDA?

Getting hired by the FDA can be competitive due to the specialized nature of the roles and the high standards for education, experience, and security clearances. Candidates often need relevant degrees, such as in science or public health, and may undergo rigorous background checks and assessments. Strong technical skills and knowledge of regulatory processes can improve chances of employment.

What are some typical challenges faced by professionals working at the FDA, and how can they be managed?

Professionals at the FDA often navigate complex regulatory requirements, tight deadlines, and the need to balance public health priorities with industry innovation. Collaborating across multidisciplinary teams and staying updated on evolving scientific data are essential parts of the role. Adapting to frequent changes in policy and handling high volumes of submissions can be demanding, but leveraging strong communication skills and seeking mentorship within the agency can help manage these challenges effectively.

What are the key skills and qualifications needed to thrive as an FDA (U.S. Food and Drug Administration) Regulatory Affairs Specialist, and why are they important?

To thrive as an FDA Regulatory Affairs Specialist, you need a strong background in life sciences, regulatory guidelines, and compliance, usually supported by a relevant degree such as pharmacy, biology, or chemistry. Familiarity with regulatory submission systems, FDA regulations (such as 21 CFR), and certifications like RAC (Regulatory Affairs Certification) are highly beneficial. Attention to detail, strong analytical thinking, and effective communication skills help professionals navigate complex regulations and collaborate with cross-functional teams. These competencies ensure that products meet legal requirements and safety standards, facilitating successful approvals and market access.

What does an FDA (Food and Drug Administration) professional do?

An FDA professional works for the U.S. Food and Drug Administration, a federal agency responsible for protecting public health by ensuring the safety and efficacy of drugs, medical devices, food, cosmetics, and other products. Their roles can include reviewing and approving new drugs and medical devices, conducting inspections, enforcing regulations, and providing guidance to industries. FDA professionals may also work in research, policy development, and public outreach to ensure that products meet regulatory standards and are safe for consumer use.

What is the highest paying job at the FDA?

The highest paying jobs at the FDA are typically senior leadership roles such as the Commissioner of Food and Drugs or Deputy Commissioner, which can have salaries exceeding $200,000 annually. These positions require extensive experience, advanced degrees, and often involve overseeing regulatory policies and organizational management.

How do I get into the FDA?

To work at the FDA, candidates typically need a relevant bachelor's degree in fields like science, engineering, or healthcare, along with experience in regulatory or scientific roles. Positions often require passing background checks and may involve specialized training or certifications depending on the role. Applying through USAJOBS and demonstrating knowledge of FDA regulations and policies is essential.

What is the difference between Fda vs Food Scientist?

AspectFdaFood Scientist
Required CredentialsTypically a degree in health, science, or related field; certifications varyBachelor's or master's in food science, microbiology, or related
Work EnvironmentRegulatory agencies, laboratories, inspection sitesFood manufacturing facilities, laboratories, research settings
Employer & Industry UsageU.S. Food and Drug Administration, government agenciesFood companies, research institutions, government agencies
Common Search & Comparison IntentUnderstanding regulatory roles, compliance, and enforcementFood safety, product development, research

While both Fda professionals and Food Scientists work within the food industry, Fda roles focus on regulation, compliance, and enforcement of food safety laws, often within government agencies. Food Scientists primarily engage in research, product development, and ensuring food quality in manufacturing settings. The two careers overlap in food safety knowledge but differ in their primary responsibilities and work environments.

More about Fda jobs
What cities are hiring for Fda jobs? Cities with the most Fda job openings:
What are the most commonly searched types of Fda jobs? The most popular types of Fda jobs are:
What states have the most Fda jobs? States with the most job openings for Fda jobs include:
What job categories do people searching Fda jobs look for? The top searched job categories for Fda jobs are:
Fda jobs near you
Infographic showing various Fda job openings in the United States as of June 2026, with employment types broken down into 84% Full Time, 13% Part Time, 2% Contract, and 1% Nights. Highlights an 90% Physical, 1% Hybrid, and 9% Remote job distribution, with an average salary of $81,844 per year, or $39.3 per hour.
Clinical Data Scientist, FDA (Jr.)

Clinical Data Scientist, FDA (Jr.)

DRT Strategies, Inc.

Silver Spring, MD • On-site

$90K - $120K/yr

Full-time

Posted 13 days ago

Job description

Overview
DRT Strategies delivers expert management consulting and information technology (IT) solutions to large federal agencies, state and local government and commercial clients in health care, technology, and financial services industries.
The three letters of our name, DRT, stand for Driving Resolution Together, which is the core philosophy on which the company was founded. That is, we collaborate with our clients to solve their most pressing challenges - together.
We are problem solvers dedicated to your success, combining Fortune 500 experience with small business responsiveness. We have established a reputation with our clients as a forward-thinking consulting firm with demonstrated success in implementing solutions that lead to meaningful results. Our world-class consultants unite people to work collaboratively to achieve project goals and make vision a reality.
Project Description:
The Clinical Analyst contractor position provides scientific and clinical analytical support to CDER Office of New Drugs (OND) multi-disciplinary review teams. The individual will assist in the evaluation of drug applications, review clinical safety data, labeling assessment, and preparation of scientific reports. The work requires advanced knowledge in health and data sciences and
the ability to apply scientific expertise to support risk determinations in the context of regulatory review.
Note: This is a support role. All regulatory decisions, final recommendations, and official communications with applicants remain the exclusive responsibility of qualified FDA
federal employees. The contractor's work products are subject to review and approval by FDA staff.
Job Summary:
The Clinical Analyst position interacts with many FDA stakeholders across several Offices and Centers specifically with clinical reviewers (Medical Officers) and statistical reviewers. This role will be responsible for reviewing safety data sufficiency and integrity, conducting safety data analyses, verifying safety data submitted by the applicant, and generating high-quality scientific reports.
Responsibilities:
Clinical Data Analysis and Review
  • Analyze and evaluate submitted data from applicants seeking permission to market new drugs for general use and prepare analytical summaries on the adequacy of safety data provided.
  • Review NDAs, BLAs, supplements, and amendments; prepare draft analytical reports and recommendations for FDA reviewer consideration.
  • Incorporate summaries from clinical safety data reviews as part of integrated multi-disciplinary assessments. Prepare, oversee, and maintain project schedules.
Labeling Review Support
  • Assist in the review of proposed drug labeling to assess whether safety claims are truthful and adequately supported,
  • Provide draft safety data analyses on labeling accuracy and completeness for review by FDA staff.
Scientific Correspondence and Reporting
  • Draft scientifically sufficient reports of findings that clearly communicate clinical safety analyses and conclusions.
  • Prepare draft correspondence identifying facts and information inadequately presented in sponsor submissions, for FDA reviewer finalization and issuance.
  • Prepare clear summaries of clinical safety data tables, figures and listings for FDA review team use.
Literature Review and Knowledge Management
  • Review scientific literature and maintain awareness of current clinical developments and evolving findings in relevant therapeutic areas. Support preparation of background materials for seminars, conferences, and industry meetings.
  • Stakeholder Support
  • Support clinical review teams in preparing for meetings with drug company representatives, advisory committees, and external scientific bodies.
Other Tasks
  • Lead meetings with clinical reviewers and statistical reviewers to present results from data quality assessments and standard safety data analyses.
  • 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 controlled terminology and safety dataset structure.
  • Interact with government and contractor teams to help manage and monitor project progress, risk, issues, and track action items.
  • Manage, organize, and update SharePoint sites.
  • Assist in overall project support, as needed.
  • Support any other DRT tasks as assigned/requested by Portfolio Manager and Account Lead.
Required Experience:
  • Minimum of 3 years professional experience.
  • Technical proficiency in programming languages- R (mandatory) with demonstrated experience using R for data manipulation, analysis, and visualization in a clinical or regulatory research context.
  • R programming - ability to troubleshoot errors in R.
  • Experience with CDISC data standards (including SDTM and ADaM) and safety dataset structure (e.g., adsl.xpt, adae.xpt, adlb.xpt, advs.xpt, and adeg.xpt)
  • Understands data analytical methods (e.g., longitudinal analysis, time-to-event analyses, and causal/correlation analyses) for conducting safety data analyses (tables and figures)
  • Understands safety review elements including trial design, demographics, exposure, death, discontinuation, dose modification, SAE, TEAE, FMQ, AESI, laboratory tests, and vital signs. Working knowledge of safety analysis methods, including the evaluation of adverse event data, safety signal detection, and the preparation of standardized safety tables and figures.
  • Strong analytical and statistical skills to assess safety data.
  • Excellent organizational, time management, verbal and written communication skills.
  • Ability to independently manage a variety of projects with frequent interruptions and shifting priorities.
  • Ability to organize a continuous flow of work in a timely manner and meet mandatory deadlines.
  • Computer skills: MS Office Suite (particularly PowerPoint, Word, Excel), Adobe Acrobat.
  • Ability to work independently within a multidisciplinary team.
Preferred Experience:
  • Proficiency in manipulating data using R programming.
  • Experience and/or knowledge of analytical software including JReview, JMP, JMP Clinical, etc.
  • Experience in SAS programming.
  • Ability to apply knowledge of scientific research principles, study design concepts, and methods sufficient to evaluate clinical drug development programs.
  • Experience in applying clinical safety data analytical skills, including the ability to synthesize clinical and scientific evidence to inform risk assessments.
  • Experience in clinical trials, especially statistical hypothesis testing methods. Understands general concept of clinical trial design and drug development (e.g., adequate and well-controlled studies).
  • Statistical background, including experience with biostatistical methods commonly
    applied in clinical trial design, analysis, and interpretation (e.g., survival analysis, mixed-
    effects models, hypothesis testing).
  • Machine learning and AI background, including familiarity with predictive modeling
    techniques (e.g., classification models, regression models, random forest, or neural
    networks) and their potential applications in drug safety evaluation and regulatory science.
  • Epidemiological background, including experience with observational study design, real-world evidence, pharmacoepidemiology, or population-level safety surveillance methods.
  • Ability to work with little direct supervision on loosely defined tasks and coordinate work across multiple projects.
  • Experience identifying, articulating, and resolving complex, unique, and previously unresolved.
  • Familiarity with FDA regulatory process and/or working experience at FDA.
Education & Training:
  • PharmD or PhD in the STEM disciplines: bioinformatics, Public Health, Pharmacology, Toxicology, Biology, Biomedical Engineer, biology, biostatistics, epidemiology, health informatics, or pharmaceutical science.
Work Authorization, Clearance Requirement, & Additional Information:
  • This position requires the ability to obtain and maintain a U.S. government Public Trust clearance. Due to contract requirements, candidates must be U.S. citizens or lawful permanent residents (green card holders) to be eligible.
  • No agencies, third parties, or Corp-to-Corp submissions.
Salary Range:
  • $90,000-120,000
  • Salary commensurate with experience.

DRT Strategies, Inc. (DRT) follows the guidelines outlined by the Equal Employment Opportunity Commission (EEOC) to provide all employees and qualified applicants employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related conditions, transgender status, and sexual orientation), national origin, age, genetic information, disability, protected veteran status, or any other protected characteristic under federal, state, or local law.
Reasonable accommodations for applicants and employees with disabilities will be provided. If a reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact Human Resources by emailing HR@drtstrategies.com, or by dialing 571-482-2517.
For additional information, please review the Know Your Rights: Workplace Discrimination is Illegal, E-Verify (English), E-Verify (Spanish). Right to Work (English), Right to Work (Spanish).
Please be aware of recruitment fraud where malicious individuals might pose as DRT Strategies. Only job postings and emails from drtstrategies.com are authentic and legitimate communications regarding DRT Strategies employment opportunities. Please contact Human Resources at hr@drtstrategies.com if you believe you have received a fraudulent email.

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