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Regulatory (and Start-up Specialist) I or II, Budapest

IQVIA Holdings Inc.

Budapest, Hungary

IQVIA is a leading global provider of contract research services, advanced analytics and technology solutions to the life sciences industry formed through the merger of IMS Health and Quintiles.

IQVIA Hungary is looking for a Regulatory (and Start-up Specialist) I or II based in Budapest to join our multi-sponsor RSU team. This person will manage the start-up process of clinical studies, being part of a high performing team with great potential to further develop.

Main Accountabilities

  • Perform submission related activities to the Hungarian Regulatory Authority/Central Ethics Committee according to applicable regulations, Standard Operational Procedures and work instructions;
  • Managing patient facing material translation and review;
  • Ensure that country essential documents and RA/EC approval are granted, and specific project deliverables are completed;
  • Review, establish and agree on project planning and project timelines;
  • Oversight assigned projects on country level during the submission phase;
  • Cooperate and communicate with the local management, Regulatory Specialist, Centralized RSU, Global Study Team, Regulatory Expert, Investigators and other site staff, CRAs;

Requirements

  • BSc/MSc degree preferably in Scientific/Life Science field (Pharmacy, CTF, Biology, Chemistry etc.);
  • Previous experience in clinical research;
  • Previous experience with regulatory submissions;
  • Proficiency in English (written and spoken) and Hungarian language
  • Excellent Microsoft Office Skills;
  • Good communication  and time management skills;
  • Team player;
  • Ability to be multi-tasking in a fast-paced environment;

Why should you apply?

  • You'd join a global team of 70.000+ brave minds
  • In 2020 we completed almost 4.000 recruitment processes internally; once you join us, not even the sky is the limit
  • We've been nominated a FORTUNE top 500 company every year since our inception in 2016
  • FLEXJOBS awarded us the 9th spot in the top 100 Companies for Remote Jobs in 2021

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

Job posted: 1970-01-01

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