ICON plc
ICON plc
ICON plc स्वास्थ्य सेवा और फार्मास्युटिकल उद्योगों को सेवाएँ प्रदान करने वाला एक वैश्विक कॉन्ट्रैक्ट रिसर्च संगठन है। इसका कार्य क्लिनिकल, परामर्श और वाणिज्यिक सेवाओं तक फैला है, जो शुरुआती अनुसंधान से लेकर विपणन-पश्चात गतिविधियों तक दवा विकास में सहायता करती हैं। कंपनी विकेंद्रीकृत क्लिनिकल परीक्षण, हृदय सुरक्षा, प्रारंभिक क्लिनिकल प्रयोगशालाएँ, मेडिकल इमेजिंग, नियामक इंटेलिजेंस और वास्तविक-विश्व साक्ष्य जैसी सेवाएँ प्रदान करती है। ICON plc हृदय रोग, ऑन्कोलॉजी, आंतरिक चिकित्सा, सेल और जीन थेरेपी तथा बायोसिमिलर जैसे क्षेत्रों में चिकित्सीय विशेषज्ञता भी उपलब्ध कराती है। डेटा विश्लेषण और रोगी-केंद्रित दृष्टिकोणों को मिलाकर कंपनी क्लिनिकल कार्यक्रमों को आगे बढ़ाने में मदद करती है।

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.

विवरण

  • 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

आवश्यकताएँ

  • 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

लाभ

  • 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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