FDA Jobs in Chicago, IL

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Python Developer - (clinical data)

Radiant System, Inc

•

Remote

Contract

Seeking a Python Developer with strong experience in clinical data standards (SDTM/CDISC) and a background in the pharmaceutical industry. Role involves developing automation pipelines and AI/ML models to transform clinical trial data into SDTM-compliant datasets. Must-Haves: 8+ years in pharma/clinical domain 3+ years Python development SDTM, CDISC, ADaM, raw datasets Experience with AI/ML (NLP, classification) Tools: Pinnacle 21, Define.xml Nice-to-Have: Metadata-driven automation Knowledge of
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Posted 19 hours ago

Quality Lab Associate II, 2nd Shift

BAXTER

•

Elk Grove Village, Illinois, USA

Full-time

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform h
Posted 4 days ago | Updated 7 hours ago

Senior Biostatistician

Georgia IT

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Remote

Contract

Senior Biostatistician Remote Duration: 12+ Months Rate: DOE At least 8years of experienceIn Addition to the above Statistical Programming II experienceLead statistical aspects of clinical studies from design to final reportingReview and approve programming deliverables (ADaM datasets, tables, listings, and figures)Proven expertise in SAS and/or R for statistical analysisMentor junior biostatisticians and support team developmentEnsure compliance with industry standards (CDISC, ICH, FDA/EMA gu
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Posted 16 hours ago

Senior Biostatistician

System Edge (USA) L.L.C.

•

Remote

Contract

Position: Senior Biostatistician Location: Remote/EST time zone Contract- Long termAt least 6-8years of experienceIn Addition to the above Statistical Programming II experienceLead statistical aspects of clinical studies from design to final reportingReview and approve programming deliverables (ADaM datasets, tables, listings, and figures)Proven expertise in SAS and/or R for statistical analysisMentor junior biostatisticians and support team developmentEnsure compliance with industry standards (
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Posted 14 hours ago

SAP GTS Business Function Implementation Lead (Remote Work)

Source Code Technologies LLC

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Remote

Contract, Third Party

We are seeking an experienced SAP GTS Consultant with expertise in Global Trade Services (GTS), including full lifecycle implementations and hands-on configuration in SAP GTS E4H. The ideal candidate will have deep functional knowledge of compliance management, customs processes (exports/imports), and GTS master data, particularly in trade between the Dominican Republic (DR) and the US.This is a client-facing, lead role requiring strong project leadership, ability to drive results, and hands-on
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Posted 10 days ago

Data Science/ML Engineer

People Force Consulting Inc

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Remote

Contract

We are seeking a highly skilled Senior Machine Learning Engineer to join the Foundational Data Analytics (FDA) Program, a strategic initiative focused on building a modern, intelligent data ecosystem. This role will lead the design, development, and deployment of machine learning models that support enterprise-wide analytics, predictive insights, and healthcare transformation. FDA Program Objectives: Single Source of Truth (SSOT): Build standardized, high-quality data infrastructure ensuring con
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Posted 1 day ago | Updated 7 hours ago

clinical Python Developer (100% Remote)

AKAASA Technologies

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Remote

Contract

Required: Master's degree with 8+ years of experience in clinical or pharma settings and 3+ years of experience in Python development Strong understanding of SDTM standards and CDISC requirements. Experience with AI/ML techniques, including data preprocessing, classification, and NLP (e.g., for mapping clinical terms). Familiarity with tools like Pinnacle 21, Define.xml, and clinical trial data structures. Excellent problem-solving and collaboration skills. Experience working with clinical trial
Posted 16 hours ago

Senior Biostatistician: Pharma experience / Remote

Biogensys

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Remote

Contract

Biogensys is currently hiring Senior Biostatistician with Pharma experience for 6 to 12 months contract on w2. This is a remote position, no corp to corp, or 1099. No sponsorship is available. Senior Biostatistician: Pharma experience / Remote- At least 9-10 years of experienceLead statistical aspects of clinical studies from design to final reportingReview and approve programming deliverables (ADaM datasets, tables, listings, and figures)Proven expertise in SAS and/or R for statistical analysis
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Posted 2 days ago

Python Developer

Hired by Matrix, Inc.

•

Remote or Nutley, New Jersey, USA

Contract

At-a-Glance: Are you ready to build your career by joining a global pharmaceutical company. If so, our client is hiring a Python Developer.Position Type: Contract RemoteRequired: Master s degree with 8+ years of experience in clinical or pharma settings and 3+ years of experience in Python development Strong understanding of SDTM standards and CDISC requirements. Experience with AI/ML techniques, including data preprocessing, classification, and NLP (e.g., for mapping clinical terms). Familiarit
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Posted 20 hours ago | Updated 8 hours ago

Principal Regulatory Consultant Dietary Supplements

Apptad Inc

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New Jersey, USA

Third Party, Contract

Job Description: Job Title: Principal Regulatory Consultant Dietary Supplements (U.S.-Based) Position Type: Contract / Consulting Location: Jersey City, NJ Department: Regulatory Affairs / Corporate Development Position Summary: We are seeking a highly experienced and credentialed Regulatory Consultant to support strategic M&A due diligence initiatives within the dietary supplement industry. This role demands deep understanding of the U.S. regulatory landscape, including DSHEA, FDA cGMPs (21 CFR
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Posted 10 days ago

Document Management Specilist (W2 Only - 100% Remote)

Performix Business Services, LLC

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Remote or Rochester, Minnesota, USA

Contract

Learn Division of Engineering tools and expectations.Document controls system (SolidWorks PDM) structure, navigation, and use.Engineering change order process.Document templates.Assist with document revisions from annual review. For each document:Accept redlines from document owner (facilitate review?).Review documents and suggest further incremental improvements.Verify reference documents section.Documents referenced in text are included in reference section.Documents in reference section exist
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Posted 3 days ago | Updated 2 days ago

Quality Lab Associate II, 2nd Shift

BAXTER

•

Hanover Park, Illinois, USA

Full-time

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform h
Posted 4 days ago | Updated 7 hours ago

Laboratory Information Management System (LIMS) /ELN Consultant, MN/REMOTE - Direct Client

Javen Technologies, Inc

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Remote

Contract, Third Party

Javen Technologies Direct Client is looking for Laboratory Information Management System (LIMS)/Electronic Lab Notebook (ELN) Consultant in Maplewood MN. 100% REMOTE opportunity. If interested, please reach me at / - Gowri. Domain Knowledge: Experience with LIMS (Laboratory Information Management Systems) preferably LabVantage Understanding of clinical, research, or diagnostic lab workflows Knowledge of regulatory requirements (GxP, FDA 21 CFR Part 11) Familiarity with lab instruments, integra
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Posted 18 hours ago

IT Project Lead V - LIMS Project Manager

Javen Technologies, Inc

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Remote

Third Party, Contract

Job Title: IT Project Lead V Location: Remote. Duration: 15+ Months (Extendable) Duties: This role will assist with the implementation of a new Laboratory Information Management System (LIMS) and Electronic Lab Notebook (ELN) to be used across the organization starting in 2026. Domain Knowledge: Experience with LIMS (Laboratory Information Management Systems) preferably LabVantageUnderstanding of clinical, research, or diagnostic lab workflowsKnowledge of regulatory requirements (GxP, FDA 21 CFR
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Posted 19 hours ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's
Posted 15 days ago | Updated 1 hour ago

Statistical Programmer

System Edge (USA) L.L.C.

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Remote

Contract

Statistical Programmer Anywhere in US EST time zone- candidate need to work in EST time Key responsibilities At least 5 years of experience in ADaM/TLF.Create, validate, and maintain SAS programs for data analysis, reporting, and submission deliverablesDevelop analysis datasets (ADaM) and tables, listings, and figures (TLFs) to support statistical analysis in production side.Collaborate with statisticians and data managers to define dataset specifications and outputsEnsure compliance with inter
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Posted 14 hours ago

Appian Developer || 100% Remote

AKAASA Technologies

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Remote

Contract

Position: Appian Developer Location: 100% Remote Duration: 6+Months Interview: Phone and Video Job Description: Preferred: Current or previously held Public Trust Clearance or government security clearance 100% Remote 6 month contract to permanent hire w/ GDIT Note: Will obtain a govt. public trust clearance while on the project/program Appian Developer General Dynamics Information Technology is seeking a Senior Appian Developer to join our team supporting the FDA. The Food and Drug Administra
Posted 20 hours ago

CQV Engineer

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Job Description: We are seeking a highly motivated and experienced CQV Engineer to join PharmEng Technology, a leading global provider of engineering and consulting services to the pharmaceutical and biotechnology industries. The CQV Engineer will lead commissioning, qualification, and validation activities for new and existing pharmaceutical facilities and equipment. Responsibilities: Develop and execute commissioning, qualification, and validation protocols for new and existing pharmaceutical
Posted 4 days ago | Updated 1 hour ago

Remote QA Manager with Healthcare Payer and Claims exp

Infinite Computer Solutions (ICS)

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Remote

Full-time

Note : GCEAD, L2EAD, consultant can apply for this position who can work on W2. Job Summary: We are looking for an experienced QA Healthcare Manager to lead the quality assurance team in ensuring the reliability, security, and compliance of healthcare applications. The ideal candidate should have a strong background in healthcare software testing, regulatory compliance (HIPAA, CMS, FDA), test automation, and team leadership. Key Responsibilities: we need someone who understand healthacre paye
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Posted 16 days ago | Updated 7 days ago

Senior Clinical SAS programmer with Pharma experience -Remonte-W2 -Contract

Biogensys

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Remote

Contract

Biogensys is currently hiring a Senior SAS programmer with Pharma experience for 6 to 12 months contract on w2. This is a remote position, no corp to corp, or 1099. No sponsorship is available. Statistical Programmer II: Pharma experience/Remote At least 7-8 years of experience in ADaM/TLF.Create, validate, and maintain SAS programs for data analysis, reporting, and submission deliverablesDevelop analysis datasets (ADaM) and tables, listings, and figures (TLFs) to support statistical analysis in
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Posted 2 days ago