Company Description

PSI is a leading Contract Research Organization with 30 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 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.

Hybrid in Kyiv, Ukraine

Your role will include:

• Liaising with clinical project teams to procure documents required for regulatory & ethics committee submissions
• Preparation of regulatory and ethics committee submission dossiers
• Review of translations of essential documents subject to clinical trial submissions
• Tracking regulatory project documentation flow and progress reporting
• Tracking changes/amendments to legislation requirements related to clinical research
• Maintaining the database of regulatory requirements
• Communication point for ethics committees and regulatory authorities
• Ensuring accurate and timely reporting to ethics committees and regulatory authorities
• Communication line for clinical project teams and PSI support services on regulatory matters
• Delivering regulatory-related training, as required

Qualifications

• College/University degree in Pharmacy, Medicine, Life Sciences, or an equivalent combination of education, training and experience
• Prior experience with clinical trial submissions in Ukraine and knowledge of local regulatory environment
• Full working proficiency in English and Ukrainian
• Proficiency in standard MS Office applications
• Excellent communication, planning and organizational skills
• Demonstrated ability to multi-task and work effectively in a fast-paced environment
• Team oriented with excellent customer service and interpersonal skills, including a positive attitude to tasks and projects

Additional Information

We offer:

• Flexible working conditions
• Extensive training and friendly team
• Competitive salary and benefits package
• Opportunities for personal and professional growth

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.

Please submit your CV in English.