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Clinical Trial Reg Affairs Specialist II
Pharmaceutical Product Development (PPD)
Remote, Mexico
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.
Job posted: 2024-02-16