FDA Jobs in Seattle, WA

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Senior Clinical SAS programmer with Pharma experience -Remonte-W2 -Contract

Biogensys

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

Sr. Principal Statistics

PARAKEET WORLD SOLUTIONS LLC

Remote

Contract

Job Title: Sr. Principal StatisticsLocation: Remote Duration: 6 MonthsEmployment Type: W2 ContractExperience Level: Mid-SeniorEducation Required: Ph.D. or MS in Statistics or BiostatisticsIndustry: Pharmaceuticals Job Summary:The Sr. Principal Statistician will lead statistical activities in clinical trials, from protocol development to final study reporting. The role will also contribute to regulatory filings, in-licensing evaluations, and marketing support. Key Responsibilities:Review protocol

Clinical Data manager

Intone Networks Inc.

Remote

Contract, Third Party

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

JD EDWARD DEVELOPER

Virisha LLC

Remote

Contract

JD Edwards E1 Developer 100% REMOTE but open to working core CST hours 6 month contract to hire Job Description: PREFERRED QUALIFICATIONS: Experience with JDE 9.2+ and Tools Release 9.2.x.Familiarity with BI Publisher, JDE Security, and Workflow.Experience integrating JDE with third-party systems using REST/SOAP APIs.Background in Agile/Scrum or DevOps environments.DUTIES AND RESPONSIBILITIES: Lead the design, development, and implementation of complex customizations and enhancements in JD Edw

Job Title: Product Manager Healthcare Remote

Think Big Solutions, Inc

Remote

Contract

Job Title: Product Manager Healthcare Location: [City, State or Remote] Job Type: [Full-Time / Part-Time / Contract] Job Summary: We are seeking an experienced and strategic Product Manager with a background in healthcare to lead the development and execution of products that improve patient outcomes, provider workflows, or payer efficiency. The ideal candidate will have a strong understanding of healthcare systems, regulations (e.g., HIPAA, HL7, FHIR), and the complexities of healthcare deliver

Sales head

Showman Staffing

Remote

Full-time

Job Title: Sales Head Experience: 6+yrs Location: Remote-Travel required(100% travel) Job: Permanent Full Time Requirement Role Overview We are seeking a passionate and driven Sales professional to accelerate our growth in the Healthcare and MedTech space one of the most rapidly evolving sectors today. You will work with a high performing team targeting innovative healthcare providers, MedTech firms, and digital health disruptors to bring cutting-edge technology solutions to life. You will repr

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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

Senior Commissioning, Qualification & Validation (CQV) Engineer

Johnson & Johnson

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

Lead Engineer - MES Opcenter

Katalyst Healthcares and Lifesciences

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

Engineer III, Validation

Thermo Fisher Scientific

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

Cloud Engineer

ICF

New Jersey, USA

Full-time

Please note: This role is contingent upon contract award. While it is not an immediate opening, we are actively conducting interviews and extending offers in anticipation of the award. The Work We are seeking a skilled and security-focused Cloud Engineer to support mission-critical systems for our federal government client. The ideal candidate will have experience architecting, deploying, and managing cloud solutions in compliance with government cybersecurity frameworks such as FedRAMP, NIST,

Senior Appian Developer

General Dynamics

Remote

Full-time

Type of Requisition: Pipeline Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: Other Job Family: Software Engineering Job Qualifications: Skills: Appian (Platform), Appian BPM, Appian Process Automation Certifications: None Experience: 5 + years of related experience ship Required: No Job Description: General Dynamics Information Technology is seeking numerous candidatesto fill multiple-level Appian Developer roles on

Sr. R&D Engineer

Johnson & Johnson

Remote or New Brighton, Minnesota, 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

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

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

Data Architect/ Engineer(Remote)

Kellton

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

Remote Senior Appian Developer

Computer Merchant, Ltd., The

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

Director, Device Engineering

Gilead Sciences, Inc.

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

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

Saama Technologies, LLC

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

Senior Manager, Data Analytics

Quest Diagnostics Inc.

Remote or Wood Dale, Illinois, USA

Full-time

Overview Reporting to the Director, Program Management QA/RA, the Sr. Manager, Data Analytics - Quality & Regulatory Affairs will lead the development, management, and execution of a best-in-class analytics strategy in support of the QA/RA function. This position is responsible for establishing on-going processes for collecting and transforming data into strategic insights that support risk management, regulatory compliance, operational excellence, and governance reporting. This is a highly vi

Engineer III, Validation

Thermo Fisher Scientific

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