Job Description

　　PV RA MW Coordinator

　　• Provides support and coordination of review of safety and regulatory publishing documents on receipt.

　　• Assists in reviewing document quality when tracking safety and regulatory publishing data in internal systems and uploading in internal and/or external electronic trial master files.

　　• Ensures redactions for Commercially Confident Information and Personal Data for regulatory publishing is maintained.

　　• Assists in maintaining the upkeep of licenses within internal and/or external systems for users across projects within IT Security standards.

　　• Coordinates/facilitates project meetings, drafts meeting minutes, posts minutes/materials to client portals and distributes to internal and external project teams.

　　• Manages project specific training and the set-up, maintenance and archival of program files; ensuring audit readiness.

　　• Identifies and redacts subject and client confidential identifiers per local requirements, retrains sites and escalates reoccurrences to PPD Data Privacy.

　　• Performs data entry into internal/external databases, tracking systems and PPD's budget management system; performs system reconciliations to identify issues which may negatively impact project timelines.

　　• Oversees expenses and manages translations; ensuring budget parameters are not exceeded.

　　• Assist with archiving of regulatory publishing documents and submissions.

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.