Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products while taking a step further in your professional career.
Office-based or remote
Your role:
- Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities including Import and Export license applications
- Communicate with regulatory authorities ethics committees project teams and vendors on regulatory-related matters
- Review translations of essential documents subject to clinical trial submission
- Track the regulatory project documentation flow
- Review documents to greenlight IP release to sites
- Manage safety reporting to authorities
- Deliver regulatory training to project teams
- Assist with feasibility research and business development requests
Qualifications :
- College/University degree or an equivalent combination of education training and experience
- Prior experience with clinical trial submissions in Trkiye
- Full working proficiency in English and Turkish
- Proficiency in MS Office applications
- Detail-oriented
- Ability to learn plan and work in a dynamic team environment
- Communication collaboration and problem-solving skills
Additional Information :
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people then PSI is the right choice for you.
Remote Work :
Yes
Employment Type :
Full-time