Clinical Trial Submission Manager Associate

ICON plc

Istanbul, Turkey
Fluent in turkish language
1-2 years regulatory affairs experience
Bachelor's degree in scientific field
The role involves designing and analyzing clinical trials while interpreting complex medical data to advance innovative treatments

Job Summary

  • The role involves designing and analyzing clinical trials while interpreting complex medical data to advance innovative treatments.
  • Responsibilities include managing notifications to Ethics Committees, handling amendment submissions, and overseeing the printing and shipping of dossiers.
  • ICON offers a competitive salary along with comprehensive benefits including health insurance, retirement planning, and global employee assistance programs.

Matching Summary

The role involves designing and analyzing clinical trials while interpreting complex medical data to advance innovative treatments.

Skills & Requirements

Must-have

  • Fluent in Turkish language
  • 1-2 years regulatory affairs experience
  • Bachelor's degree in scientific field
  • Proficiency in CT/IND submission processes
  • Experience with EC and RA portal management

Nice-to-have

  • Advanced degree preferred
  • Familiarity with label review requirements
  • Strong attention to detail
  • Excellent communication skills
  • Global activity involvement capability

Key Requirements

  • Minimum 1-2 years experience in pharmaceutical regulatory affairs
  • Bachelor's degree in science or healthcare required
  • Fluency in Turkish language mandatory
  • Knowledge of MAA/NA variations and DSUR/PSUR renewals

Work Rights

Not specified

Tailored Resume

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