Specialist, Regulatory & Site Activation - South Korea- Remote

Worldwide Clinical Trials

South Korea
Minimum three years clinical research experience
Mandatory regulatory submission experience in south korea
Thorough knowledge of ich gcp and eu clinical trials directive
The role involves liaising with colleagues to drive the timely and high-quality submission of regulatory documents for clinical trials

Job Summary

  • The role involves liaising with colleagues to drive the timely and high-quality submission of regulatory documents for clinical trials.
  • Candidates must maintain country-specific patient information sheets, consent forms, and drug labeling information compliant with local regulations.
  • Worldwide Clinical Trials is a global team of over 3,500 experts committed to improving lives through pioneering approaches to curing diseases.

Matching Summary

The role involves liaising with colleagues to drive the timely and high-quality submission of regulatory documents for clinical trials.

Skills & Requirements

Must-have

  • Minimum three years clinical research experience
  • Mandatory regulatory submission experience in South Korea
  • Thorough knowledge of ICH GCP and EU Clinical Trials Directive
  • Strong written and verbal communication in English and Korean
  • Proficiency in MS Office applications

Nice-to-have

  • Multilingualism beyond English and local language
  • Experience within pharmaceutical or CRO industry
  • Ability to initiate relationships with local investigators
  • Understanding of country-level cultural norms
  • Aptitude for planning and strategizing in fast-paced environments

Key Requirements

  • Four-year college degree in medical, biological, or related sciences
  • Three years of experience in clinical research or regulatory functions
  • Previous experience within the pharmaceutical or CRO industry
  • Mandatory experience in regulatory submissions specifically in South Korea

Work Rights

Not specified

Tailored Resume

Cover Letter