FDA jobs in Jersey City, NJ

New York, New York

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19d ago

10+ years of experience in a regulatory or compliance role within the Life Sciences industry. Contribute to the Intelligence & Practice, related to the daily regulatory content service, writing articles, providing input, and participating in interviews. Stay on top of regulatory changes in the industry. Work closely with product teams to ensure innovative solutions meet specific compliance requirements. Host and lead industry roundtables, facilitate discussions on compliance practices, speak on

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Full-time

$200,000 - $250,000

Senior Director of Information Technology

Hybrid in White Plains, New York

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Today

In office Tues, Wed and Thursday JOB SUMMARY: The Senior Director of Information Technology is responsible for the planning, organizing, and execution of all IT Software business applications and related projects to ensure optimal functioning of IT/business systems. This role involves working with new solutions, procurement, and maintenance of software programs. MAJOR RESPONSIBILITES/ACTIVIES: Analyzes complex business needs presented by the user community and/or clients and recommends technical

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Full-time

BASED ON EXPERIENCE

Salesforce Business Analyst (BA)

New Brunswick, New Jersey

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12d ago

Business Analyst with Salesforce (functional) expertise someone who has worked as a Business Analyst on Salesforce projects, understands Service/Experience Cloud, and can collaborate with devs/admins to implement solutions. Client need Strong Business Analyst (BA) background requirement gathering, stakeholder management, documentation, ROI analysis, regulatory compliance along with Salesforce hands-on (Service Cloud & Experience Cloud) should be able to understand configurations, workflows, and

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Contract, Third Party

SAP Test Automation Delivery Lead

Remote or Hybrid in California

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Today

Job Title: SAP QA Automation ( Tosca ) Lead Duration: 18 Months+ Location PST - 100% Remote Exp. Level: 10+ years Job Description Our client is looking for a TOSCA certified automation engineer who has experience to Lead automation strategy and delivery across SAP implementation projects, ensuring consistency and compliance (GxP, FDA). Client is looking for Pharma / BioTech domain in background. Key Responsibilities: Lead automation strategy and delivery across SAP implementation projects, ensu

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Full-time, Contract

BASED ON EXPERIENCE

Supply Chain Project Manager

Remote

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6d ago

Job Title: Project / Product Manager -Supply Chain SME Location: Remote Duration: 6+ Months Job Description: Key Responsibilities: Work with the Director, Product and Technology teams to lead and manage end-to-end project execution from initiation to completion, ensuring projects are delivered within scope, budget, and timeframe. Collaborate with the various stakeholder groups to define project objectives, requirements, and success criteria, aligning them with the organization objectives. Devel

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Contract

Depends on Experience

Statistical Software Configuration Specialist (Statistica TIBCO)

Remote or Hybrid in Vacaville, California

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Today

Statistical Software Configuration Specialist (Statistica TIBCO) Vacaville, CA / A hybrid model (once or twice in the office) / Remote Duration: - 6-12 Months+ For a "Statistica Software configuration specialist" role, which likely involves both data analytics and potentially on-site manufacturing support or collaboration, a hybrid model (once or twice in the office) is a probable arrangement. Statistical Software Configuration Specialist (Statistica TIBCO) Position Overview The Statistical Soft

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Contract, Third Party

Depends on Experience

SAP PPQM PTS Consultant Remote

Remote or Atlanta, Georgia

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Yesterday

Job Id: #CGEMJP00321513 Title: SAP PPQM PTS Consultant Location: Remote Duration: 12+ Months Position Summary: Job Role and Responsibilities: We are looking for a highly skilled Senior SAP PPQM Consultant with over 6 years of experience in SAP Production Planning (PP) and Quality Management (QM) modules, specifically within the pharmaceutical industry. The ideal candidate will have a deep understanding of GxP compliance, regulatory requirements, and validation documentation. This role involv

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Full-time, Part-time, Contract, Third Party

Full Stack Engineer

Remote

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Today

Full Stack Engineer - Remote (EST)Responsibilities Collaborate with your team to design, develop, test, deploy, and maintain secure, compliant SaaS solutions Build and enhance software features to address customer challenges and improve user experience Drive continuous improvement efforts and support CI/CD processes throughout the development lifecycle Promote and implement automation to streamline workflows, reduce manual effort, and ensure consistency Engage in all stages of product deve

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Full-time

$135000

Process Engineer

Fair Lawn, New Jersey

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Today

Job Description: The Quality Process Engineer will be responsible for developing and maintaining process control systems to ensure consistent product quality, with a focus on supporting the insourcing of materials and components. This role leads cross-functional efforts to qualify internal processes, validate materials, and transition manufacturing activities from external suppliers. The engineer ensures compliance with GMP, GDP, and regulatory standards while driving process improvements, suppo

Full-time

Clinical SAS programmer

Tarrytown, New York

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Today

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.

Full-time

Project Manager

Madison, New Jersey

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Today

Description A leading global organization is seeking a highly experienced Senior Project Manager to support the Chief Information Security Officer (CISO) in driving strategic cybersecurity and risk-management initiatives across the enterprise. This role will lead complex, cross-functional programs aligned to regulatory compliance, security modernization, risk remediation, data protection, and IT governance. You will partner closely with Cybersecurity Leadership, Infrastructure, Applications, Le

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Contract

USD 55.41 - 64.16 per hour

Associate-Director, Human Factors and Usability Engineering

Morristown, New Jersey

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Today

Job Title: Associate-Director, Human Factors and Usability Engineering Location: Morristown, NJ Cambridge, MA About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. The Associate Director will be responsible for leading and executi

Full-time

USD 147,000.00 - 212,333.33 per year

Validation Engineer

New Brunswick, New Jersey

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Today

Job Description: Computerized Systems Validation (CSV) position involves ensuring that GxP-regulated computer systems and software comply with current Good Manufacturing Practices (cGMP) regulations, international guidelines (like 21 CFR Part 11 and Annex 11), and company standards by validating their functionality throughout their lifecycle. Key responsibilities include developing and reviewing validation documentation (protocols, reports), performing risk and impact assessments, coordinating

Full-time

Director of DevOps & Containerization (pharma)

Edison, New Jersey

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5d ago

A leading pharmaceutical organization focused on innovation in research and drug delivery, is seeking a Director of DevOps and Containerization to drive the modernization of cloud infrastructure, CI/CD pipelines, and container orchestration strategy. This is a hands-on leadership role, ideal for an engineer-manager with deep technical experience in automation, infrastructure-as-code, and container platforms, combined with strategic oversight of development and deployment workflows across the ent

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Full-time

$160,000 - $220,000

Engineering Specialist

Millburn, New Jersey

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Today

Job Description Summary At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Manufacturing professionals to help us reach our ambitious goals. The Team Lead, Maintenance will execute engineering activities (design, implementation, maintenance, etc.) within technical area of expertise by using reliable and cost-effec

Full-time

USD 85,400.00 - 158,600.00 per year

Director, Digital Assets, Financial Crimes Models & Analytics

Jersey City, New Jersey

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Today

Job Description:Director, Digital Assets, Financial Crimes Models & AnalyticsThe RoleWe?re seeking a Digital Assets Director to serve as a subject-matter expert and to lead the team directly/indirectly responsible for the development and maintenance of innovative cryptocurrency transaction monitoring and trade surveillance solutions. In this 100% crypto-focused role you will partner with Data Engineers, Data Scientists, Business Intelligence and Compliance professionals to oversee the buildout,

Full-time

Compensation information provided in the description

Regulatory Strategy Consultant

Remote or Hybrid

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Today

Position: Regulatory Strategy Advisor (FDA Approval Process) Location: Remote Duration: 6-12 months (fractional engagement) <>Overview We are seeking an experienced Regulatory Strategy Advisor to guide a medical technology organization through the FDA approval process for a neuro-electric medical device. This role is critical in ensuring compliance with FDA guidelines, minimizing organizational risk, and providing strategic oversight throughout the regulatory journey. <>Key Responsibilities

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Contract

$100 - $250 per hour

TA Head of Biostatistics, Neuroscience and Ophthalmology

Morristown, New Jersey

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Today

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

Full-time

Regulatory System Manager

Remote

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18d ago

Summary: We are seeking a highly technical and detail-oriented Regulatory Systems Manager to oversee our digital compliance and submission activities. This role is critical for managing our interactions with global health authorities, including the FDA and the EU's EUDAMED database, through modern electronic data exchange protocols. Key Responsibilities:EUDAMED Management: Serve as the company's subject matter expert (SME) for the EUDAMED database, responsible for data submission, device registr

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Contract

$80+

Associate Director Quantitative Data Modeling

Morristown, New Jersey

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Today

Job Title: Associate Director Quantitative Data Modeling Location: 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 Quantitative Pharmacology (QP) organization at Sanofi is dedicated to ensuring the safe and effective therapeutic treatment of patients by applying sound pharmacokinetic (

Full-time

USD 147,000.00 - 212,333.33 per year

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FDA jobs in Jersey City, NJ, USA