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

Your role:

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 strategyPrimary responsibility for discussing submission strategy with sponsorsIdentifying regulatory risks and working on mitigation plansManaging 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 mattersReview translations of essential documents subject to clinical trial submissionTrack the regulatory project documentation flowReview documents to greenlight IP release to sitesManage safety reporting to authoritiesDeliver regulatory training to project teams Assist with feasibility research and business development requests

QualificationsCollege/University degree or an equivalent combination of education, training and experienceA 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 CzechProficiency in MS Office applicationsDetail-orientedAbility to learn, plan and work in a dynamic team environmentCommunication, 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.