- Cardinal Health (Indianapolis, IN)
- … validation , and/or transfer protocols, analytical equipment qualification protocols, or computer system validation test scripts, as needed. + Performs ... of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device) preferred. + Has experience in authoring… more
- Cardinal Health (Indianapolis, IN)
- …(California Consumer Privacy Act), FDA (Food and Drug Administration)/GxP/CSV ( Computer System Validation ), DSCSA(Drug Supply Chain Security Act), as well ... as relevant governance frameworks to drive compliance to those regulatory requirements such as NIST, HITRUST, SOC 2, ISO, COBIT, ITIL, etc., while working with members of the Information Security and Risk Management team as well as stakeholders from Finance,… more
- Sumitomo Pharma (Indianapolis, IN)
- …+ Assist in signal detection activities including data assembly, signal validation , and signal evaluation. + Perform literature monitoring (with vendor support) ... oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and… more
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