FDA Jobs in New York, NY

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Process Engineer

Katalyst Healthcares and Lifesciences

•

Morristown, New Jersey, USA

Full-time

Responsibilities: Support activities within MSAT-US regarding technical documentation, SOP's, and internal systems. Development of technical positions regarding packaging and Pharma process, equipment, material and component performance and Regulatory compliance for Company packaging process practices. Investigating and recommending new packaging and Pharma processes, technologies, systems, and materials, for potential integration into Company packaging and Pharma manufacturing systems. Provi
Posted 60+ days ago | Updated 11 hours ago

Sanitation Director

WinMax Systems Corporation

•

Linden, New Jersey, USA

Full-time

Title: Sanitation DirectorLocation: Linden, NJ OR Lancaster, TX with Travel Full Time Job Description: We are seeking a strategic and results-driven Sanitation Director to lead the development, implementation, and oversight of a standardized sanitation program across our manufacturing network. This high-impact, corporate-level role will be instrumental in streamlining operations, enhancing regulatory compliance, and driving continuous improvement through unified processes. The ideal candidate wi
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Posted 21 days ago

Associate Software Engineer (SQL/Javascript/Python), Lab Information Systems

Quest Diagnostics Inc.

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Secaucus, New Jersey, USA

Full-time

Job Description Pay Range: $100,00.00 - $120,000.00 / year Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual performance bonus compensation. Benefits Information: We are proud to offer best-in-class benefits and programs to support employees and their families in living healt
Posted 2 days ago | Updated 11 hours ago

USA-Process Engineer III (Engineering)

Katalyst Healthcares and Lifesciences

•

Morristown, New Jersey, USA

Full-time

Responsibilities: Support activities within MSAT-US regarding technical documentation, SOP's, and internal systems. Development of technical positions regarding packaging and Pharma process, equipment, material and component performance and Regulatory compliance for Client packaging process practices. This includes investigating and recommending new packaging and Pharma processes, technologies, systems, and materials, for potential integration into Client packaging and Pharma manufacturing sys
Posted 60+ days ago | Updated 11 hours ago

Engineer III, Validation

Thermo Fisher Scientific

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Remote or Fair Lawn, New Jersey, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you're part of Thermo Fisher Scientific, you'll do meaningful work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the
Posted 60+ days ago | Updated 11 hours ago

Senior Engineer, Product Development - R&D

Stryker

•

Mahwah, New Jersey, USA

Full-time

Work Flexibility: Hybrid or Onsite Stryker Joint Replacement Division, based in Mahwah, NJ, Hip Business Unit is currently seeking a Senior Engineer, Product Development (PD) to support the Hip Business Unit. Know more about the Joint Replacement Hip Unit: Hip Business Unit What You Will Do: Device Design & Problem Solving: Research, design, develop, modify, and verify mechanical components for medical devices; translate design inputs into engineering specifications; and apply , both fundamen
Posted 8 days ago | Updated 11 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Warren, New Jersey, USA

Full-time

Responsibilities: Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures. Develops protocols, and associated reports while adhering to a change management process. Supports the execution of equipment qualifications and validation protocols. Supervises vendors for qualification functions. Supports calibration, equipment qualification and validation activities. Configures and documents the configuration of computerized systems. Dev
Posted 51 days ago | Updated 11 hours ago

Technical Lead AWS

Trigent Solutions

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Remote

Full-time

Job Title: Technical Lead AWS (AI/ML Experience Preferred) Client: U.S. Food and Drug Administration (FDA) Position Type: Full-time | Permanent Location: 100% Remote Job Summary: We are seeking a highly skilled Technical Lead to support our ongoing initiatives with the FDA. The ideal candidate will have a strong technical background, leadership experience, and a passion for innovation, with machine learning (AI/ML) experience being a strong plus. This is a long-term, fully remote opportunity wi
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Posted 1 day ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Summit, New Jersey, USA

Full-time

Position Overview: The CSV Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. With minimum supervision and given general instructions, this individual carries out routine tasks and functions and uses basic
Posted 60+ days ago | Updated 11 hours ago

Senior Biostatistician

Georgia IT

•

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 5 days 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 5 days ago

Data Science/ML Engineer

People Force Consulting Inc

•

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 6 days ago | Updated 14 hours ago

Statistical Programmer

Georgia IT

•

Remote

Contract

Job Title: Statistical Programmer Location: Remote Key Responsibilities Develop, validate, and maintain SAS programs for statistical analysis, regulatory submission, and reporting deliverables. Create analysis datasets (ADaM) and tables, listings, and figures (TLFs) for clinical trial data analysis. Collaborate with statisticians and data managers to define specifications for datasets and statistical outputs. Ensure compliance with CDISC standards, internal SOPs, and regulatory guidelines (FDA,
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Posted 4 days 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 7 days ago

Regulatory CMS Senior Manager

Sureminds Solutions

•

Remote

Contract, Third Party

C2C Role Please share Profiles at Hi, Urgent need, Job Title: Regulatory Studio CMS Senior Manager Work location: New Brunswick (preferred), Lawrenceville Monday thru Friday - Normal business hours, with some flexibility 50% onsite - Team is onsite Monday thru Thursday Top 3 to 5 skills/Must Haves: Small Molecule Drug development experience (2 to 3 years) Good communications skills (written/verbal) Experience with Veeva System PREREQUISITES BS/BA degree in Scientific Discipline (master's or hig
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Posted 1 day ago | Updated 18 hours ago

Senior Outcomes Specialist

E-Solutions, Inc.

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California, USA

Third Party

Job title: Senior Outcomes Specialist Location: Remote Mandatory Skills: SQL, SAS, R, or Python, Healthcare What's in it for you :- We are seeking a results-driven and analytical Senior Outcomes Specialist to support the Foundational Data Analytics (FDA) Program. This role will focus on measuring, analyzing, and improving clinical, operational, and financial outcomes across the enterprise. The ideal candidate will bring deep expertise in healthcare analytics, outcomes measurement, and perfor
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Posted 1 day ago | Updated 7 hours ago

Field Service Engineer, Immuno Diagnostics (NY/NJ)

Thermo Fisher Scientific

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Remote or New York, New York, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift Job Description Job Description Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. At Thermo Fisher Scientific, each one of our 100,000 plus extraordinary minds has a uni
Posted 60+ days ago | Updated 11 hours ago

Principal Regulatory Consultant Dietary Supplements

Apptad Inc

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New Jersey, USA

Contract, Third Party

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 15 days ago

Sr. Biostatistician needed for Remote Job longterm Contract!!!

Nam Info Inc

•

Remote or US

Third Party, Contract

Dear, Hope you are doing well. Send resumes along with expected bill rates on W2( NO Benefits) or Independent contractors only apply and share to Note : NO 3rd party candidates, or H1's/EAD's/OPT's please. Role : Sr. Biostatistician Location:Remote Duration : 6+ months contract EST time zone- candidate need to work in EST time Skills: At least 8years of experience In Addition to the above Statistical Programming II experience Lead statistica
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Posted 4 days ago | Updated 16 hours ago

Senior Information Security Analyst - Research (Remote)

Northwell Health

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Remote or New Hyde Park, New York, USA

Full-time

Job Description Collaborates closely with Research Information Security Specialist and Enterprise Digital Services (EDS) IT Security team to develop and implement security measures and controls for research platforms and applications. Plans, designs, implements, and provides ongoing support for the organization security technologies. Assists other associates with regard to training and work assignments. Job Responsibility Conduct comprehensive IT audits to assess the adequacy and effectiveness
Posted 60+ days ago | Updated 18 hours ago