Clinical Trial Reg Affairs Specialist II

Job Description

• Act as an administrator for our in-house Regulatory Intelligence database and provide customer support for issues arising.
• Regulatory collaboration with Regulatory Intelligence database workflow users to drive quarterly EQR metrics.
• Contribute to a wide range of technical Regulatory Intelligence database content projects including engineering and re-engineering of content structure and uniformity. The latter may involve developing content (as FIL) in collaboration with CICs/CILs (e.g., new Regulatory Intelligence database tables).
• IQ, OQ, PQ testing of modifications to Regulatory Intelligence database.  Troubleshooting of Regulatory Intelligence database.
• Analyze and report on changes to document requirements (e.g., internal reports to CTMS and to Regulatory Intelligence database value added reports).
• Act as Regulatory Intelligence database workflow user as required and permitted per SOPs.
• Supports compliance in Regulatory Intelligence through spot-checking intel, supporting in-country associates updating intel.
• Coordinate survey, and analysis of Regulatory Intelligence database users & metrics.
• Contribute to RIPA reports for feasibility, bids, bid defense, and other aspects of business development.
• Manages, supports, and responds to ad hoc regulatory intelligence queries.
• Takes lead role for authoring and compiling Regulatory Intelligence newsletters.
• Manages stand-alone regulatory intelligence projects (client-facing).
• Interfaces with PPD project teams, sponsors and Regulatory Authorities as required.
• Develops collaborative working relationships with in-country associates and project teams.
• Ensures compliance with relevant organizational and department SOPs and WPDs.