Regulatory Operations Associate II

Job Description

Support to CPDS (Chemical and Pharmaceutical Development & Supply) team (1 FTE): Training management (Curricula maintenance and updating, daily follow-up for trainings, Instructor Lead Course (ILC) creation, new users/existing users training management in Compliance wire (CW), etc. Electronic Lab Notebook (ELN) support activities (spreadsheet validation, periodic review of users, user groups, templates etc. Tru‐ vault Docs handling (controlled prints, uploading & routing of documents for review/approvals, Projects, SOPs, work instructions (WI), forms etc. Activities related to upgradation of existing systems/software (e.g. Windows 10 migration, Project Olympus, RIMS 5 etc.) Responsible for computerized System Validation Scientific support systems like Deskman, FR5, Open lab, Empower as well as compliance and few DI aspects etc. Learn more about our EEO & Accommodations request here.