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      $95-$122/hr

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      New York, NY 10025

      Education AssistanceHealth InsuranceRetirement Benefit
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      New York, NY 10025

      Health Insurance
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      Genmab

      Plainsboro, NJ 08536

      RemoteEducation AssistanceHealth InsurancePaid Time OffRetirement Benefit

      • Demonstrated experience serving as Business or Application System Owner for a GxP platform, preferably in a SaaS or cloud-hosted model.
      • Experience reviewing vendor validation documentation and leading UAT/regression testing in a regulated environment.
      • Bachelor's or Master's degree in statistics, biostatistics, computer science, or related field.
      • Experience supporting inspection readiness, internal audits, and regulatory inspections.
      • 10+ years of experience in pharmaceutical/biotech environments supporting validated GxP computerized systems.
      • Experience operating within a vendor-based validation model and assessing business impact of SaaS platform releases.
      • Practical knowledge of statistical programming environments (e.g., SAS, R) and associated file, package, and workflow management.
      • Strong working knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, GxP SDLC, change control, and data integrity principles (ALCOA+).
      SmartExplore AI is experimental.
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      $36-$41/hr
      ~ 29 min OnsiteEducation AssistanceHealth InsurancePaid Time OffRetirement Benefit

      • Oncology Data Specialist, ODS, by the National Cancer Registrars Association is required with working knowledge of medical terminology, anatomy, physiology, oncology disease process, coding, and staging.
      • Minimum of an Associate degree in any health-related field
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