ICON plc
ICON plc
ICON plc este o organizație globală de cercetare în regim contractual, care deservește industriile din domeniul sănătății și farmaceutic. Activitatea sa cuprinde servicii clinice, de consultanță și comerciale care sprijină dezvoltarea medicamentelor, de la cercetarea timpurie până la activitățile post-comercializare. Compania oferă soluții precum studii clinice descentralizate, evaluarea siguranței cardiace, laboratoare clinice pentru etapele timpurii, imagistică medicală, informații de reglementare și dovezi din lumea reală. ICON plc dispune, de asemenea, de expertiză terapeutică în domenii precum bolile cardiovasculare, oncologia, medicina internă, terapiile celulare și genice și medicamentele biosimilare, combinând analiza datelor cu o abordare axată pe pacienți pentru a contribui la avansarea programelor clinice.

Regulatory Technician – CTIS Submissions | ICON plc | Spain Remote

Support CTIS data management, document uploads, and regulatory submissions for ICON plc’s clinical research operations. Coordinate submission activities and stakeholder follow-up to help advance medicines to patients.

Descriere

  • Manage activities in the Clinical Trials Information System (CTIS)
  • Support submissions and related documents, including their assembly and dispatch
  • Coordinate resources supporting regulatory submissions
  • Identify and help mitigate CTIS data-management and document-upload risks through helpdesk support
  • Work with internal and external stakeholders to resolve submission-related issues
  • Maintain study-level account access for assigned CTIS projects
  • Complete data entry and upload documents in CTIS
  • Monitor CTIS activity and alert relevant stakeholders when action or follow-up is needed
  • Prepare records of CTIS submissions, conclusions, decisions, and communications
  • Conduct quality-control reviews in line with applicable procedures
  • Keep submission work aligned with agreed timelines
  • Complete project-specific training within the required timeframe

Cerințe

  • Advanced English proficiency is required for speaking, reading, and writing
  • One to two years of relevant clinical research experience or familiarity with clinical terminology and documentation is preferred
  • Able to work independently
  • Regulatory submission and CTIS experience is advantageous but not required
  • Must have the legal right to work in the country where the role is based

Beneficii

  • Base salary with performance-related incentives
  • Health and wellbeing programmes, including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Structured training and career development pathways
  • Reasonable accommodations throughout the recruitment process
  • Inclusive and accessible workplace

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