Ctis (clinical Trial Information System) - Team Specialist

Roche

Base: 2,400 eur grosspmnthly; bonus/equity: annual...
Hybrid
Eu cta submission portal management
Clinical trial information system (ctis)
Regulatory dossier compilation and submission
This role focuses on managing the administration of the EU CTA submission portal and coordinating the lifecycle of Clinical Trial Applications

Job Summary

  • This role focuses on managing the administration of the EU CTA submission portal and coordinating the lifecycle of Clinical Trial Applications.
  • The position offers development opportunities including free language courses, training, and the possibility of international assignments within a global diverse community.
  • Salary starts from 2400 EUR gross/monthly with benefits including an annual bonus, transportation allowance, and hybrid work model options.

Matching Summary

This role focuses on managing the administration of the EU CTA submission portal and coordinating the lifecycle of Clinical Trial Applications.

Salary

Base: 2400 EUR gross/monthly; Bonus/Equity: Annual Bonus mentioned; Benefits: Transportation allowance, Health Insurance, Home Office setup

Skills & Requirements

Must-have

  • EU CTA submission portal management
  • Clinical Trial Information System (CTIS)
  • Regulatory dossier compilation and submission
  • Health Authority inquiry response coordination
  • Veeva Regulatory Information Management proficiency

Nice-to-have

  • Experience with CTI or CTD dossier structures
  • Biotech or pharmaceutical industry background
  • Process improvement and automation assessment
  • Strong written and spoken English communication
  • Additional language skills based on region

Key Requirements

  • Minimum BA or BS degree in biology, chemistry, pharmacy, or related field
  • Previous experience with regulatory data and documents
  • Proficiency in broad range of IT skills and data management

Work Rights

Not specified

Tailored Resume

Cover Letter