FDA Jobs in New York

21 - 40 of 94 Jobs

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Summit, 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 equipment qualification and systems validation activities. Configures and documents the configuration of computerized systems. Develops

Process EngineerJob Title - Process Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

Sanitation DirectorJob Title - Sanitation Director

WinMax Systems CorporationCompany Name - WinMax Systems Corporation

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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

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

Quest Diagnostics Inc.Company Name - 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

USA-Process Engineer III (Engineering)Job Title - USA-Process Engineer III (Engineering)

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

Engineer III, ValidationJob Title - Engineer III, Validation

Thermo Fisher ScientificCompany Name - 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

Senior Engineer, Product Development - R&DJob Title - Senior Engineer, Product Development - R&D

StrykerCompany Name - Stryker

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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

Senior Clinical Outcomes Assessment (COA) LeadJob Title - Senior Clinical Outcomes Assessment (COA) Lead

SanofiCompany Name - Sanofi

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Morristown, New Jersey, USA

Full-time

Job Title: Senior Clinical Outcomes Assessment (COA) Lead Location: Cambridge, MA, Morristown, NJ About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. The remit of the Clinical Outcome Assessment (COA) team at Sanofi is to incorporate the patients' perspective (and other subjective perspectives) into clinica

GRA CMC Project LeadJob Title - GRA CMC Project Lead

SanofiCompany Name - Sanofi

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Morristown, New Jersey, USA

Full-time

Job Title: GRA CMC Project Lead Location: Morristown, NJ Framingham, MA About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. The Chemistry, Manufacturing and Controls (CMC) regulatory team is accountable for the global regulatory strategy for development and marketed products within GRA. The team responsibil

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

Technical Lead AWSJob Title - Technical Lead AWS

Trigent SolutionsCompany Name - 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

Director, Global Regulatory Affairs - Global Labeling StrategyJob Title - Director, Global Regulatory Affairs - Global Labeling Strategy

SanofiCompany Name - Sanofi

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Morristown, New Jersey, USA

Full-time

Job Title: Director, Global Regulatory Affairs - Global Labeling Strategy Location: Morristown, NJ (preferred), Cambridge, MA, Swiftwater, PA or Washington, DC About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. The Director, Global Regulatory Affairs - Global Labeling Strategy is responsible for leading the

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

TA Head of Biostatistics, Neuroscience and OphthalmologyJob Title - TA Head of Biostatistics, Neuroscience and Ophthalmology

SanofiCompany Name - Sanofi

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Morristown, New Jersey, USA

Full-time

Job Title: Data Governance Location: Cambridge, MA Morristown, NJ About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. Join our Biostatistics Neuroscience and Ophthalmology teamas Global Head of Neuroscience and Ophthalmology TA Biostatistics. You will beleading and overseeing all statistical work for clinica

Senior BiostatisticianJob Title - Senior Biostatistician

Georgia ITCompany Name - 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

Senior BiostatisticianJob Title - Senior Biostatistician

System Edge (USA) L.L.C.Company Name - System Edge (USA) L.L.C.

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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 (

Data Science/ML EngineerJob Title - Data Science/ML Engineer

People Force Consulting IncCompany Name - 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

Statistical ProgrammerJob Title - Statistical Programmer

Georgia ITCompany Name - Georgia IT

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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,

Senior Biostatistician: Pharma experience / RemoteJob Title - Senior Biostatistician: Pharma experience / Remote

BiogensysCompany Name - 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

The Head of EGDS Innovation and Center of ExcellenceJob Title - The Head of EGDS Innovation and Center of Excellence

SanofiCompany Name - Sanofi

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Morristown, New Jersey, USA

Full-time

Job Title: The Head of EGDS Innovation and Center of Excellence Location: Morristown, NJ , Cambridge, MA About the job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where