인재풀 - Country Approval Specialist (ssu)

Thermo Fisher Scientific UK

Gangnam, Seoul, South Korea
Hybrid
Country submissions management
Local regulatory submissions
Regulatory strategy advice
Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts

Job Summary

  • Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts.
  • Manages the preparation, review and coordination of Country Submissions in line with global submission strategy and prepares, review and coordinates local regulatory submissions (EC, additional special national local applications if applicable).
  • Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided and directs/mentos other SIA individuals assigned to support projects of responsibility.

Matching Summary

Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts.

Skills & Requirements

Must-have

  • Country Submissions management
  • Local regulatory submissions
  • Regulatory strategy advice
  • Investigator and regulatory authority liaison
  • Clinical trial site activation

Nice-to-have

  • Team building skills
  • Mentoring ability
  • Proactive issue identification
  • Grant budget negotiation

Key Requirements

  • 2+ years of relevant experience
  • Bachelor's degree or equivalent
  • Excellent English language skills
  • Knowledge of regional/national regulatory guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter