Company Description
PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Job Description
Join our team of experts in regulatory 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.
Hybrid working arrangement in Prague, the Czech Republic

QUALIFICATIONS

• College/University degree or an equivalent combination of education, training and experience
• A minimum of 5 year’s experience with clinical trial submissions in the Czech Republic (experience in Slovakia is an advantage)
• Extensive experience with Clinical Trial Information System (CTIS)
• Full working proficiency in English and fluent in Czech
• 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

• Prepare and oversee the preparation of clinical trial submission
• Acts as a Regulatory Lead in complex clinical trials and programs of clinical trials: coordination of CTIS submission, shared responsibility for developing global and country-level submission strategy
• Primary responsibility for discussing submission strategy with sponsors
• Identifying regulatory risks and working on mitigation plans
• Managing consistency of approaches and regulatory processes across multiple trials in programs of clinical trials
• 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