Teams at Parexel

Develop CMC regulatory strategies and prepare, coordinate, and review GMP-related submissions for biologic, small-molecule, and combination products. Support FDA, EMA, and Health Canada filings from early development through post-approval, provide regulatory guidance to cross-functional teams, address manufacturing and quality issues, and prepare for health authority meetings. Maintain global stakeholder relationships and improve regulatory processes and systems.

Supports sponsors with project management and operational execution for digital pathology in clinical development. Coordinates whole-slide image transfers, vendor follow-up, request tracking, process documentation, compliance activities, and stakeholder communications. The role works cross-functionally with scientific and operational teams to ensure digital pathology workflows are organized and delivered on schedule.

Supports clinical research projects across their lifecycle by maintaining project plans, reports, metrics, budgets, systems, compliance records, and action items. Assists with project initiation, vendor coordination, study supplies, invoice review, meetings, CTMS reporting, and operational closeout. The role collaborates with Project Leaders and Functional Leads to ensure quality, timely delivery, financial oversight, and regulatory compliance across global projects.