Competitive salary; various annual leave entitleme...
Hybrid
Proficient knowledge of ich/gcp guidelines
Experience with icon sops and systems
Ability to assemble critical document packages
ICON plc is a world-leading healthcare intelligence and clinical research organization dedicated to shaping the future of clinical development
Job Summary
ICON plc is a world-leading healthcare intelligence and clinical research organization dedicated to shaping the future of clinical development.
The role involves supporting site partners to collect, review, and assemble regulatory submission packages for Central EC/IRB and Local authorities in compliance with ICH/GCP.
Candidates will ensure accuracy of the Critical Document Package, manage TMF documents, and forecast site activation plans to meet project timelines.
Matching Summary
ICON plc is a world-leading healthcare intelligence and clinical research organization dedicated to shaping the future of clinical development.
Salary
Competitive salary; Various annual leave entitlements; Health insurance and retirement planning offerings
Skills & Requirements
Must-have
Proficient knowledge of ICH/GCP guidelines
Experience with ICON SOPs and systems
Ability to assemble Critical Document Packages
Knowledge of local regulatory requirements in Taiwan
Skills in Trial Master File management
Nice-to-have
Strong collaboration with internal stakeholders
Proactive risk identification and mitigation
Effective communication for translation coordination