FDA Jobs in Raleigh, NC

21 - 40 of 72 Jobs

Specialist, Purification Technical Engineering HPV (DS4)Job Title - Specialist, Purification Technical Engineering HPV (DS4)

Merck & Company IncCompany Name - Merck & Company Inc

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Durham, North Carolina, USA

Full-time

Job Description The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. This state-of-the-art facility established in 2004, manufactures our lifesaving vaccines in bulk and finished forms. Due to the importance of this facility in our Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years; currently Durham employs 1,000+ people. Durham's Technology Transfer Specialist will be an energetic,

MES Systems EngineerJob Title - MES Systems Engineer

Eli Lilly and CompanyCompany Name - Eli Lilly and Company

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Durham, North Carolina, USA

Full-time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined

Remote QA Manager with Healthcare Payer and Claims expJob Title - Remote QA Manager with Healthcare Payer and Claims exp

Infinite Computer Solutions (ICS)Company Name - 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

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

BiogensysCompany Name - 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

Sr. Principal StatisticsJob Title - Sr. Principal Statistics

PARAKEET WORLD SOLUTIONS LLCCompany Name - PARAKEET WORLD SOLUTIONS LLC

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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 managerJob Title - Clinical Data manager

Intone Networks Inc.Company Name - Intone Networks Inc.

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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

RTP MES Systems EngineerJob Title - RTP MES Systems Engineer

Eli Lilly and CompanyCompany Name - Eli Lilly and Company

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Durham, North Carolina, USA

Full-time

Senior Specialist, Purification Technical Engineering HPV (DS4)Job Title - Senior Specialist, Purification Technical Engineering HPV (DS4)

Merck & Company IncCompany Name - Merck & Company Inc

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Durham, North Carolina, USA

Full-time

JD EDWARD DEVELOPERJob Title - JD EDWARD DEVELOPER

Virisha LLCCompany Name - Virisha LLC

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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 RemoteJob Title - Job Title: Product Manager Healthcare Remote

Think Big Solutions, IncCompany Name - Think Big Solutions, Inc

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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 headJob Title - Sales head

Showman StaffingCompany Name - Showman Staffing

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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

DTS Lead - Intelligent Clinical Supply ManagementJob Title - DTS Lead - Intelligent Clinical Supply Management

Quantum Integrators Group LLCCompany Name - Quantum Integrators Group LLC

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Remote or King of Prussia, Pennsylvania, USA

Third Party, Contract

Role Name: DTS Lead - Intelligent Clinical Supply Management (ICSM) Location: King of Prussia, PA. REMOTE 6+ Months contract Job Description The DTS Lead ICSM is responsible for leading the design, implementation, and optimization of SAP's Intelligent Clinical Supply Management (ICSM) solution. This role supports clinical trial operations by ensuring efficient planning, forecasting, packaging, labeling, and distribution of clinical trial materials across global sites, while maintaining regulato

Computer System Validation Analyst - R Studio & Clinical SystemsJob Title - Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and LifesciencesCompany Name - 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

Senior Commissioning, Qualification & Validation (CQV) EngineerJob Title - Senior Commissioning, Qualification & Validation (CQV) Engineer

Johnson & JohnsonCompany Name - 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

Lead Engineer - MES OpcenterJob Title - Lead Engineer - MES Opcenter

Katalyst Healthcares and LifesciencesCompany Name - 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

Engineer III, ValidationJob Title - Engineer III, Validation

Thermo Fisher ScientificCompany Name - 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

Cloud EngineerJob Title - Cloud Engineer

ICFCompany Name - ICF

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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 DeveloperJob Title - Senior Appian Developer

General DynamicsCompany Name - General Dynamics

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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 EngineerJob Title - Sr. R&D Engineer

Johnson & JohnsonCompany Name - Johnson & Johnson

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Remote or New Brighton, Minnesota, USA

Full-time

Sr Manager, IT Business Analysis - SAP BRH ArchitectJob Title - Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.Company Name - 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