and Pharmaceutical Environment : Demonstrated several years of experience working with Computer System Validation (CSV) within a regulated pharmaceutical context, including adherence to Good Practice (GxP) standards. Expert Knowledge in CSV : Possess excellent knowledge and understanding of CSV principles and practices. Certification as a CSV expert is highly advantageous. In-depth more »
etc) and with Gilead Sciences Global RA to ensure the success of local and international business results from the regulatory point of view Local GxP compliance expert assisting with and where appropriate leading the local regulatory activities, including internal and agency lead inspections and audits, SOP development, gap analysis and … experience in eCTD, publishing, and the use of electronic portals Experience in management of CTAs including amendments and other CT-related submissions Experience in GxP compliance Experience in review of promotional and non-promotional material per the UK and Irish industry codes of practice would be advantageous Expert project management more »
etc) and with Gilead Sciences Global RA to ensure the success of local and international business results from the regulatory point of view Local GxP compliance expert assisting with and where appropriate leading the local regulatory activities, including internal and agency lead inspections and audits, SOP development, gap analysis and … experience in eCTD, publishing, and the use of electronic portals Experience in management of CTAs including amendments and other CT-related submissions Experience in GxP compliance Experience in review of promotional and non-promotional material per the UK and Irish industry codes of practice would be advantageous Expert project management more »
etc) and with Gilead Sciences Global RA to ensure the success of local and international business results from the regulatory point of view Local GxP compliance expert assisting with and where appropriate leading the local regulatory activities, including internal and agency lead inspections and audits, SOP development, gap analysis and … experience in eCTD, publishing, and the use of electronic portals Experience in management of CTAs including amendments and other CT-related submissions Experience in GxP compliance Experience in review of promotional and non-promotional material per the UK and Irish industry codes of practice would be advantageous Expert project management more »
certification (advanced level) is required. ServiceNow Proficiency: Extensive hands-on experience with ServiceNow CMDB and related modules. Regulatory Knowledge: Familiarity with regulated environments (e.g., GxP, CSV) and related IT quality standards. Service Management Acumen: Comprehensive experience in defining and managing SLAs, KPIs, and contract-relevant service management issues. Communication Skills more »
