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IQVIA
IQVIA
Sponsor pentru viza H1BConsultanțăIndustria prelucrătoareMarketing
IQVIA combină analiza datelor din domeniul sănătății, tehnologia avansată și serviciile de consultanță pentru a ajuta organizațiile să abordeze provocări complexe din sectoarele științelor vieții și al asistenței medicale. Platforma sa Connected Intelligence reunește date și inteligență artificială pentru a sprijini cercetarea clinică, dezvoltarea tehnologică și progresul unor terapii noi. Echipele companiei lucrează în domeniile analizei datelor, consultanței și tehnologiei medicale, oferind oportunități legate de cercetare, inovare digitală și eforturi de îmbunătățire a rezultatelor pentru pacienți.
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Locurile de muncă ale companiei

Clinical Trials Regulatory Officer – Regulatory Maintenance, Belgrade

Manage clinical trial regulatory maintenance, including global submission dossiers and EU CTR filings through CTIS. Support IQVIA’s clinical research and healthcare intelligence services from its Belgrade onsite team.

RSSerbiaLa sediuNormă întreagăNivel mediuSeniorLimbă Obligatorie: englezăConformitate
Google Cloud Platform

Descriere

  • Prepare, review, and maintain global core clinical trial submission dossiers in line with regulatory requirements and company standards
  • Prepare and submit maintenance-related filings, amendments, and modifications, including EU CTR submissions through CTIS
  • Keep regulatory documentation accurate, current, and compliant throughout assigned study lifecycles
  • Advise project teams and clients on maintenance study requirements and regulatory submissions
  • Coordinate with internal and external stakeholders to deliver regulatory work and support study objectives
  • Build an understanding of project scope, timelines, deliverables, and budget considerations
  • Track regulatory activities and manage timelines proactively to meet milestones and client expectations
  • Maintain internal systems, databases, regulatory trackers, and project plans with accuracy
  • Support quality and compliance activities by keeping documentation ready for inspection and audit
  • Recognize regulatory risks, raise concerns, and help develop effective solutions

Cerințe

  • Bachelor’s degree in life sciences, pharmacy, health sciences, or a related discipline
  • At least three years of experience in clinical trial regulatory affairs, clinical research, or regulatory submissions
  • Working knowledge of Good Clinical Practice, clinical trial regulations, and submission procedures
  • Hands-on experience with the European Clinical Trials Regulation and Clinical Trials Information System
  • Strong organizational, communication, and stakeholder coordination skills
  • Ability to handle multiple priorities while preserving accuracy, quality, and attention to detail
  • High level of detail orientation and a consistent commitment to quality
  • Strong planning, organization, and time management capabilities
  • Ability to work independently and collaborate effectively in a global team
  • Effective problem-solving and critical-thinking skills
  • Customer-focused approach with strong stakeholder engagement abilities
  • Ability to balance competing demands and deliver effectively under deadlines
  • Commitment to regulatory compliance and continuous improvement

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