fda Jobs in jersey city, nj

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Clinical Data manager

Intone Networks Inc.

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Remote

Third Party, Contract

Need stronger with working on Data Acquisition, DTAs and vendor relations. Responsibilities: Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities.Assist in creating external data transfer agreements, ensuring alignment with Takeda Standards and specifications to support data integration, analysis, and reporting.Provide support in setting up infrastructure for external data to flow into T
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Posted 19 days ago | Updated 13 days ago

Global Trade Advisory /Operations Consultant

BCforward

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Remote

Contract

Global Trade Advisory /Operations Consultant BCforward is currently seeking a highly motivated Global Trade Advisory /Operations Consultant for a remote opportunity! Position Title: Global Trade Advisory /Operations Consultant Location: Remote Anticipated Start Date: ASAP Please note this is the target date and is subject to change. BCforward will send official notice ahead of a confirmed start date. Expected Duration: Initial 6 month-contract Job Type: Contract Pay Range: $85/hr-$89/hr Ple
Posted 2 days ago | Updated 6 hours ago

Compliance Lead

Adva IT Services, Inc..

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Remote

Contract

Key Responsibilities Lead the design and execution of the company s compliance framework, covering GxP areas (GMP, Google Cloud Platform, GLP) and validated system lifecycle activities. Ensure compliance with SDLC processes for GxP-relevant computerized systems, including documentation, validation, change control, and audit readiness. Develop and maintain SOPs and training programs related to software/system validation and data integrity (e.g., per 21 CFR Part 11 and Annex 11). Provide complianc
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Posted 6 days ago | Updated 1 day ago

Systems Administrator

McKesson Corporation

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Tennessee, USA

Full-time

It's More Than a Career, It's a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives
Posted 3 days ago | Updated 9 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 60+ days ago | Updated 9 hours ago

Java Developers

Catapult Solutions Group

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Remote

Full-time

Senior Full Stack Engineer (Java + Angular) Direct Hire Remote (with travel as needed for company meetings) About Company Join a forward-thinking organization delivering regulated SaaS solutions that improve the lives of end-users and meet high standards in quality, scalability, and compliance. Our collaborative environment values innovation, mentorship, and excellence in engineering practices. Job Description We are seeking a Senior Full Stack Engineer (Java + Angular)to design, develop, and ma
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Posted 6 days ago

Senior Commissioning, Qualification & Validation (CQV) Engineer

Johnson & Johnson

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Remote or Athens, Georgia, 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 17 days ago | Updated 9 hours ago

Manufacturing Technical Writer--EAM

Eliassen Group

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Anywhere, US

Contract

Description: **Hybrid onsite | 3x a week | Mesa, AZ** Our client has an exciting opportunity for a Manufacturing Technical Writer--EAM. Due to client requirement, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance. Rate: $25 - $35 / hr. w2 Responsibilities: Rewrite Process Instructions for new Asset Management system, working w
Posted 9 days ago | Updated 9 hours ago

IT Enterprise Architect with Life Science Experience

K Source Inc

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Remote

Contract, Third Party

Hi , This is Sagar from KSource Inc. We have an excellent job opportunity for you below is the JD please have a look. Job Title: IT Enterprise Architect with Life Science Experience Location: Boston, MA (Remote) Duration: 12+ months Job Description: The IT Enterprise Architect is a key role within Gates MRI IT, combing a blend of deep technical and architectural expertise with industry foresight, and strategic thinking. This position is essential for crafting a cohesive IT architecture that sup
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Posted 12 days ago

Enterprise MDM Data Governance Lead

MethodHub

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Remote

Contract

Bisoft is looking for Enterprise MDM Data Governance Lead Top Priorities: In-House Ownership: Must have deep client-side (non-consulting) experience driving enterprise MDM initiatives.Cross-Platform Expertise: Must support MDM across multiple ERPs and enterprise apps, including Salesforce, Microsoft D365, Oracle, and SAP.End-to-End Execution: Should own the full MDM roadmap from strategy to platform/tool selection, implementation, adoption, and governance.Tenure & Track Record: Preference for ca
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Posted 1 day ago | Updated 16 hours ago

Lead Engineer - MES Opcenter

Katalyst Healthcares and Lifesciences

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Remote or New York, USA

Full-time

Job Description: The Lead Engineer will lead a team of technical resources to design, develop, configure, and test MES (Manufacturing Execution Systems) solutions. They will be directly responsible for leading resources contracted vi third-party and through other Pharmaceutical organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. Responsibilities: Act as subject matter expert on system design and architecture. Solutioning and designing new
Posted 36 days ago | Updated 9 hours ago

Engineer III, Validation

Thermo Fisher Scientific

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Remote or Waltham, Massachusetts, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Engineer , Validation HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Perform technical diagnosis of operational problems, repairs, and calibrations on a wide range of laboratory equipment to ensure that the equipment is operating to the customer's complete satisfaction and manufacture specifications; Perform techn
Posted 37 days ago | Updated 9 hours ago

Enterprise MDM Data Governance Lead

MANDO TECHNOLOGIES INC

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Remote

Full-time, Contract

At Mando Technologies, we specialize in helping organizations unlock the full value of their data. From acquiring and organizing information to analyzing and delivering insights and ultimately integrating that intelligence into day-to-day operations we support the entire Business Intelligence journey from start to finish.Job Title: Enterprise MDM Data Governance Lead Employment Type: 1-Year Contract (Intent to convert to FTE) Top Priorities: In-House Ownership: Must have deep client-side (non-c
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Posted 1 day ago | Updated 4 hours ago

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

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Remote or Foster City, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro
Posted 25 days ago | Updated 10 hours ago

Data Architect/ Engineer(Remote)

Kellton

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Remote

Contract

This is a long term remote position with one of our major pharmaceutical clients. This role is 100 percent remote. SUMMARY OF POSITION: The Database Architect will be responsible for the management of Oracle and SQLServer database environments hosted at a 3rd party datacenter. The 3rd party will provide day-to-day support and monitoring services. This position will work closely with and manage the hosting partner in order to keep the environment performing to established service level agreements
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Posted 23 days ago | Updated 21 days ago

Remote Senior Appian Developer

Computer Merchant, Ltd., The

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Remote or Rockville, Maryland, USA

Full-time

JOB TITLE: Senior Appian Developer JOB LOCATION: Remote WAGE RANGE*: $75HR TO $80HR JOB NUMBER: 25-02929 REQUIRED EXPERIENCE: MUST OBTAIN A PUBLIC TRUST Skills: Appian BPM, Application Design, Software Development Experience: 10 + years of related experience JOB DESCRIPTION The Food and Drug Administration (FDA) is the federal agency responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devic
Posted 60+ days ago | Updated 6 hours ago

Software Engineer

Eliassen Group

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Anywhere, US

Contract

Description: Our client is hiring for an iOS Software Engineer to join their team in San Diego, CA. In this position, you will be designing and developing iOS applications for our core CGM devices used all over the world, to help improve the lives of people with diabetes. You will be joining a well-established team & company, on an upward growth trajectory. Due to client requirement, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits pa
Posted 9 hours ago

Director, Device Engineering

Gilead Sciences, Inc.

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Remote or Foster City, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro
Posted 38 days ago | Updated 10 hours ago

Senior Full Stack Engineer

Kforce Technology Staffing

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Remote or Orlando, Florida, USA

Contract

RESPONSIBILITIES: Kforce has a client that is seeking a Senior Full Stack Engineer to work remotely. Overview: As a Senior Full Stack Engineer, you will design, develop, and maintain web applications across both front-end and back-end systems. You'll work with technologies like Java, Angular, Spring Boot and Spring Reactive and databases to build scalable solutions. In this role, you'll collaborate with teams, teach and mentor junior engineers, and ensure high-quality code and best practices ar
Posted 7 days ago | Updated 2 hours ago

Director Contract Research Organization (CRO) SME (Customer Success)

Saama Technologies, LLC

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Remote

Full-time

Director Contract Research Organization (CRO) SME (Customer Success)Location: RemoteDepartment: Customer Success Role OverviewWe are seeking a Director level Contract Research Organization (SME) with deep expertise in Clinical Data Management (CDM) and a modern understanding of clinical data workflows and analytics. This individual will play a critical dual role in ensuring delivery excellence across customer engagements and supporting strategic sales and pre-sales efforts. This is a highly visi
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Posted 19 days ago | Updated 1 day ago