fda Jobs in new york, ny

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Validation Engineer

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
Posted 59 days ago | Updated 3 hours 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 ba
Posted 60+ days ago | Updated 3 hours ago

Business Analyst

Beacon Systems, Inc

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Remote or Jackson, Mississippi, USA

Contract, Third Party

About Beacon Systems, Inc Beacon Systems, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial, State, and Local Agencies. We are a subsidiary of Radiant Digital Solutions. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide. Position: Business Analyst Duration: 22 Months plus Location: Onsite/Remote - Jackson, MS Clie
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Posted 19 hours ago

Project Manager

Beacon Systems, Inc

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Remote

Contract, Third Party

About Beacon Systems, Inc Beacon Systems, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial, State, and Local Agencies. We are a subsidiary of Radiant Digital Solutions. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide. Position: Project Manager Duration: 22 Months plus Location: Remote Job Description: A Project
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Posted 19 hours 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 13 days ago | Updated 1 day ago

Statistical Programmer

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,
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Posted 11 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 14 days ago

Regulatory CMS Senior Manager

Sureminds Solutions

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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 8 days ago | Updated 7 days ago

Director, Clinical Quality Assurance

IO Associates

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Remote

Full-time

Director, Clinical Quality Assurance Location: Flexible (US-based) A rapidly growing biotech company advancing cutting-edge therapies for rare diseases is seeking a Director of Clinical Quality Assurance (CQA) to build and lead its Google Cloud Platform compliance strategy. Reporting to the Head of Quality, this is a high-impact leadership role responsible for designing and executing clinical quality systems across a portfolio of global early-phase gene therapy trials. Key Responsibilities: Le
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Posted 12 days ago | Updated moments 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 8 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 22 days ago

IRT Auditor

I.T. Solutions

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Remote

Contract

Role: IRT Auditor Location: Remote Type: Contract Length: 6 months Position Summary: We are seeking an experienced Oncology QA Auditor with a strong background in clinical quality assurance and a solid understanding of AI-driven technologies used in clinical trials. This role is essential to ensuring compliance across oncology programs that leverage artificial intelligence and machine learning (AI/ML) tools for clinical decision support, trial optimization, and real-world data interpretation.
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Posted 3 days 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. uthor 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 degree
Posted 20 days ago | Updated 3 hours ago

Sr. Principal Engineer, R&D

Johnson & Johnson

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Remote or Raritan, New Jersey, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 7 days ago | Updated 3 hours ago

SAP Analytics Cloud (SAC) Consultant Pharma Domain

RigelSky Inc

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Remote

Contract, Third Party

SAP Analytics Cloud (SAC) Consultant Pharma Domain Role Overview We are seeking an experienced SAP Analytics Cloud (SAC) Consultant to support analytics and reporting initiatives for a leading pharmaceutical client. The role focuses on building scalable dashboards, visualizations, and data models that enable insights across clinical operations, regulatory compliance, and commercial performance. Key Responsibilities Design and develop SAC stories and dashboards tailored to pharmaceutical business
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Posted 16 hours ago

Sr. Toxicology Associate Remote

Generis TEK Inc.

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Remote or Racine, Wisconsin, USA

Contract

We have Contract role Sr. Toxicology Associate-Remote for our client at Racine WI. Please let me know if you or any of your friends would be interested in this position. Position Details: Sr. Toxicology Associate-Remote-Racine WI Location : Racine, WI 53403 (Remote) Project Duration : 10+ Months Contract REQUIRED EDUCATION: PhD or Master s degree in toxicology or a related field TOP 5 REQUIRED SKILLS: 1. 4+ years of human health risk assessment experience 2. Proficiency in toxicity study proto
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Posted 4 days ago | Updated 5 hours ago

Process Development Engineer II - Synthetic and Bioconjugation Scale-Up

Regeneron Pharmaceutical

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Tarrytown, New York, USA

Full-time

Regeneron's Preclinical Manufacturing & Process Development group (PMPD), located in Tarrytown NY, is seeking a hardworking and dynamic Process Development Engineer II for its new Synthetic and Bioconjugation Scale-up Technologies (SBST) group. In this exciting new role, you will develop conjugation and purification processes for bioconjugation of proteins to a diverse range of small-molecules. You would work in close collaboration with cross-functional teams for process development and optimiza
Posted 60+ days ago | Updated 3 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 16 days ago | Updated 3 hours 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 29 days ago | Updated 19 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 14 days ago