Mandatory Skills: Pharma IT, GxP Project, PMP Certification

Domain Experience
• Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
• Broad knowledge of drug development process and client needs
• Prior experience working on regulatory submissions
• Familiar with 21 CFR part 11, GXP and other Life Sciences regulations

Technical Experience
• Experience with LIQUENT Insight publisher, Veeva platform strongly preferred; however, consideration will be giving to candidates with experience with other electronic publishing systems
• Experience with Waterfall and Agile development
• Thorough understanding of Software Development Life Cycle (SDLC) and all related documentation

All your information will be kept confidential according to EEO guidelines.