(JQ846) - Clinical Trial Reg Affairs Specialist Ii

(JQ846) - Clinical Trial Reg Affairs Specialist Ii

13 feb
|
Thermo Fisher Scientific
|
Nuevo Casas Grandes

13 feb

Thermo Fisher Scientific

Nuevo Casas Grandes

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.

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