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Thermo Fisher Scientific·2 months ago
2 months ago

Country Approval Specialist/ Sr. Country Approval Specialist - FSP client dedicated

SlovakiaFull-timeMid · 5-8 years

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About this role

Join our team as a Senior Country Approval Specialist and play a pivotal role in managing and coordinating regulatory submissions for leading pharmaceutical and biotech clients. Leverage your expertise in regulatory compliance and project coordination to ensure timely, high-quality submissions and support innovation in a dynamic, global environment.

Skills

  • regulatory submissions
  • ethics committee submissions
  • clinical trial site activation
  • regulatory strategy
  • patient information sheet development
  • informed consent form development
  • regulatory compliance review
  • ppd sops
  • client sops
  • medical terminology
  • negotiation skills
  • attention to detail
  • ppd tracking databases
  • planning skills
  • independent work
  • computer skills
H1B sponsor likely
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