Regulatory Affairs Assistant

7 days ago

Prague, Hlavní město Praha, Czech Republic PSI CRO Full time 300,000 - 450,000 per year
Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together 3.000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

Join our international team and support regulatory aspects of clinical research projects, streamlining communication, maintaining electronic systems and managing documents.

Hybrid working arrangement in Prague, the Czech Republic

You will:

  • Be the point of contact for clinical project teams and support services on regulatory matters
  • Prepare draft regulatory/ethics submission dossier
  • Be responsible for document management such as filing, processing, translation, quality control 
  • Update and maintain (automated) tracking systems, working files, and schedules
  • Organize meetings, prepare agendas and minutes
Qualifications
  • College/University degree or an equivalent combination of education, training & experience
  • Full working proficiency in Czech (or Slovak) and English
  • Proficiency in MS Office applications
  • Ability to plan, multitask and work in a dynamic team environment
  • Communication and collaboration skills
  • Administrative work experience, preferably in an international setting is an asset
  • Prior experience in Clinical Research is a plus
Additional Information

Start your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.

Our extensive onboarding and mentorship program will prepare you to fulfil your tasks with the highest standards, offering you:

  • Excellent and flexible working conditions.
  • A unique combination of team collaboration and independent work.
  • Competitive salary and benefits package.

If you'd like to hear more about PSI, our organic growth and company culture, and learn more about the studies that we run and our high repeat and referral business rates, please apply for this vacancy.

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