Drive global submission management strategy and activities for assigned protocols, partnering with study teams to manage regulatory activities, standards, and deliverables
Job Summary
Drive global submission management strategy and activities for assigned protocols, partnering with study teams to manage regulatory activities, standards, and deliverables.
Support and lead global team efforts to ensure high-quality, compliant submissions adhering to industry guidelines, regulatory strategies, policies, and timelines.
ICON offers a competitive salary and a range of additional benefits designed to be competitive within each country, focusing on well-being and work-life balance.
Matching Summary
Drive global submission management strategy and activities for assigned protocols, partnering with study teams to manage regulatory activities, standards, and deliverables.
Skills & Requirements
Must-have
Global submission management strategy
CTA submission development
Regulatory affairs
Health Authority submissions
Ethics Committee submissions
CTIS portal monitoring
Nice-to-have
Fostering inclusive environment
Driving innovation and excellence
Shaping future of clinical development
Team collaboration and communication
Key Requirements
B.S./B.Sc in Pharmacy, Life Sciences, Business or IT
Equivalent relevant professional experience
In-depth understanding of CTA and Central Ethics processes
Proven technical aptitude and ability to learn new software