FDA Jobs in New Jersey

Refine Results
1 - 20 of 94 Jobs

Sr Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)

Jobot

•

US

Full-time

Sr Process Design Engineer / Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast) This Jobot Job is hosted by: Tony Barhoum Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $115,000 - $150,000 per year A bit about us: We are a full-service engineering consulting firm providing services for a broad range of projects and clients within the private and public marketplaces. Our design engineers provide cost-conscious, reliable, HVAC, plumbing
Posted 1 day ago | Updated 3 hours ago

Lead IT Validation Consultant

Amaze Systems Inc

•

New York, USA

Contract, Third Party

Lead IT Validation Consultant Remote Notes : Prior experience in CROs, clinical research organizations, or pharmaceutical/biotech companies. Knowledge of laboratory processes such as PK, TK, and biomarker studies. Experience with integration of LIMS with other lab or enterprise systems (e.g., CDS, ELN, CTMS).Validation or QA certifications a plus. JD: We are seeking an experienced IT Validation Consultant to lead and support the validation of Laboratory Information Management System (LIMS) used
Easy Apply
Posted 2 days ago | Updated 2 hours ago

Business Analyst

NTT DATA Americas, Inc

•

Remote or Pittsburgh, Pennsylvania, USA

Contract

Company Overview: Req ID: 328701 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. NTT DATA's Client is currently seeking a Cybersecurity Business Analyst to join their team in Pittsburgh, Pennsylvania (US-PA), United States (US). (REMOTE)Job Description: Experience Level: 7-9 years of relevant experience Role Overview: The Business Analyst (BA) wil
Easy Apply
Posted 23 hours ago | Updated moments ago

LIMS and QC Applications Consultant

Expedite Technology Solutions

•

Remote or Bridgewater, New Jersey, USA

Full-time, Contract

Solution Architecture and Design: Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, ELN, SDMS). Define data models, interface designs, and system configurations. Implementation and Deployment: Oversee installation, configuration, and validation of LabVantage LIMS applications. Develop and execute project plans, ensuring timely an
Easy Apply
Posted 60+ days ago | Updated moments ago

GMP/Pharma Manufacturing Operator (2nd Shift)(ONSITE)

NetSource, Inc.

•

Raritan, New Jersey, USA

Contract

Please note that this is a 1-year contract. This role will be 2nd Shift 3pm 11:30PM / M F Requirements: GMP document experience. High School Diploma required; Bachelor s Degree preferred 3+ years of experience in medical device or pharmaceutical manufacturing Experience using SAP is preferred Proficient with using MS Office (Word, Excel, Outlook) Strong mechanical problem-solving ability and technical aptitude Ability to work independently with limited supervision and work as part of a team Able
Easy Apply
Posted 15 days ago | Updated 4 hours ago

Document Management Specialist | Remote | Contract

Walker Healthforce

•

Remote

Contract

Document Management Specialist | Remote | Contract Walker Healthforce is seeking a Document Management Specialist with +4 years of experience. This is a contract opportunity. CORE REQUIREMENTS:An A.A. in Business or English (or related) with four (4) years of experience OR Bachelor of Arts degree.Strong writing skills with good grammar.Attention to detail.Able to work on multiple documents in parallel.Able to create simple forms and templates.Must be able to use MS Office tools and interact with
Easy Apply
Posted 3 days ago

Statistical Programmer

Georgia IT

•

Remote

Contract

Statistical Programmer Remote Duration: 12+ Months Rate: DOE 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 internal SOPs, CDISC standards,
Easy Apply
Posted 3 hours ago

LIMS - Laboratory Information Management Systems

Javen Technologies, Inc

•

Remote

Contract, Third Party

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, integrations, and data flows Working with ELNs (Electronic Lab Notebooks) and lab automation Basic understanding of data security, validation, and integrity in lab system Skills: Business Analysis Skills: Requirements gathering and documentation Proce
Easy Apply
Posted 6 hours ago

Statistical Programmer & Senior Biostatistician

Interpro Inc.

•

Remote

Contract

Interpro has been in the IT consulting business since 1993 and our employees work on a range of projects across the country.We have a long-term opportunity as described below: Remote working-EST hours Statistical Programmer 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 pr
Easy Apply
Posted 60+ days ago | Updated 3 hours ago

Sr. Regulatory affairs Consultant-W2 ONLY

VetForce Solutions

•

Remote

Contract

Sr. Regulatory affairs Our client is a rapidly expanding biotech company based in China that recently partnered with a major pharmaceutical company for research collaboration efforts, in hopes of discovering and developing novel oral drug candidates across multiple therapeutic indications (oncology, immunology, etc.) Our client is looking to bring on a Senior Regulatory Affairs Consultant (Senior/Director Level), who will provide strategic regulatory guidance as the client navigates the regulato
Easy Apply
Posted 8 hours ago | Updated 8 hours ago

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
Easy Apply
Posted 5 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
Easy Apply
Posted 3 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 (
Easy Apply
Posted 1 hour ago

SAP GTS Business Function Implementation Lead (Remote Work)

Source Code Technologies LLC

•

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
Easy Apply
Posted 9 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
Easy Apply
Posted 22 hours ago | Updated 9 hours ago

clinical Python Developer (100% Remote)

AKAASA Technologies

•

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 3 hours ago

Senior Biostatistician: Pharma experience / Remote

Biogensys

•

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
Easy Apply
Posted 1 day 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
Easy Apply
Posted 6 hours ago | Updated moments ago

Director, Clinical Quality Assurance

IO Associates

•

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
Easy Apply
Posted moments ago

Clinical SAS Programmer

Katalyst Healthcares and Lifesciences

•

Princeton, New Jersey, USA

Full-time

Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements. Provides input in the design and development of case report forms and clinical databases.
Posted 12 days ago | Updated moments ago