- Nestle (Bridgewater, NJ)
- …and communication. + Act as a subject matter expert for the IT GxP Compliance Program. + Partner with QA to manage systems validation, periodic ... + Support Clinical Operations, Biometrics, and data management systems to ensure IT GxP compliance . GxP System Operations: + Oversee application… more
- Sanofi Group (Morristown, NJ)
- …+ Compliance of Computerized systems (REMS, GDPR, PHI, PII, GxP ) + Patient Service/Healthcare experience desired **Transversal Skills & Competencies / Soft ... cloud technologies, batch data processing, real-time API integration, and regulatory compliance for pharmaceutical or healthcare systems. The role ensures that our… more
- Sanofi Group (Bridgewater, NJ)
- …+ Compliance of Computerized systems (REMS, GDPR, PHI, PII, GxP ) + Patient Service/Healthcare experience desired **TRANSVERSAL SKILLS & COMPETENCIES (SOFT ... cloud technologies, batch data processing, real-time API integration, and regulatory compliance for pharmaceutical or healthcare systems. The role ensures that our… more
- Catalent Pharma Solutions (Somerset, NJ)
- …project teams, suppliers, site quality and IT teams acting as an expert on quality, regulatory, and compliance resource, bringing forth opportunities for the ... validation, implementation and ongoing maintenance and use of computerized GxP systems and IT infrastructure; Oversee quality...internal and supplier audits as a compliance , IT and CSV subject matter expert and… more
- Insight Global (Scotch Plains, NJ)
- …Mentor and coach other technical team members of the squad on best practices/principles. Ensure IT compliance (WICO, HIPAA, GXP , 21 CFR Part 11, Records ... ways of problem solving and implementing system improvements. Act as subject matter expert on system design and architecture. Be the single point of contact for… more
- Pfizer (New York, NY)
- …digital solutions from concept design, prototyping, to development and release. Work with R&D IT teams to identify and manage data security risks and GxP ... + If Masters: 15+ years in clinical development & operations, with expert knowledge in clinical trial conduct, clinical, monitoring& regulatory operations. + If… more
- IBM (New York, NY)
- …and customers through complexity to get results. - Understanding of life sciences compliance and computer systems validation requirements (eg, GxP , GcP). - ... develop unstructured requirements into quality requirements and translate business requirements to IT terms. - Use data analysis tools to gather insights and support… more
- J&J Family of Companies (Raritan, NJ)
- …will build reports, technical design documents and other documentation for SDLC, SOX and GxP compliance requirements ! + This role will be directly responsible ... an individual contributor who is a developing subject matter expert in a scientific/technology field. Develops actionable insights for...for day to day IT operations, resolving Incidents and supporting business teams and… more