FSP Country Approval Associate
Thermo Fisher Scientific
Support the preparation, review, and coordination of country regulatory submissions for clinical trials in alignment with global strategy. The role involves collaborating with internal departments, managing submission timelines, and maintaining regulatory documentation and databases.
Responsibilities
- Prepare, review, and coordinate ethical committee and ministry of health submissions aligned with global strategy
- Coordinate with internal departments to ensure submission activities align with site start-up timelines and critical path
- Maintain trial status information and country study files in tracking databases per company and client standard operating procedures
- Assist in developing country-specific patient information sheets and informed consent forms
- Support regulatory compliance review packages and negotiate grant budgets and payment schedules with sites
Requirements
- Bachelor's degree or equivalent formal academic/vocational qualification
- 0–2 years of relevant experience in regulatory or clinical trial support
- Strong written and oral communication skills in English
- Proficiency with computer systems and ability to learn specialized software
- Knowledge of regional and national regulatory guidelines and ethical committee regulations
- Excellent attention to detail and documentation quality
- Basic medical terminology and therapeutic area knowledge
Vaga publicada há 3 dias atrás
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