Regulatory Technician

🔥 2 hours ago

🇪🇸 Spain – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Logo of ICON plc

ICON plc

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Work with the Clinical Trials Information System (CTIS) • Provide support for submissions and other documents, including assembly and dispatch • Coordinate resources for submissions • Proactively identify and mitigate risks through CTIS helpdesks regarding data/document management and upload to CTIS • Liaise with internal and external stakeholders to resolve issues • Maintain applicable study-level account access for assigned CTIS projects • Manage and perform data entry and document uploads • Monitor CTIS and notify applicable stakeholders of activities for action and follow-up • Create files documenting CTIS submissions, conclusions, decisions, and communications • Perform quality control reviews according to applicable processes • Maintain agreed timelines • Ensure project-specific training is completed on time

🎯 Requirements

• Mandatory advanced English (speak, read, write) • Ideally 1-2 years relevant experience within clinical research or knowledge of clinical terminology and documentation • Ability to work independently • Experience with regulatory submissions and CTIS is a differential but not mandatory • Legal right to work in the country where the role is based

🏖️ Benefits

• Competitive base salary and 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 • Learning and development opportunities through structured training and career pathways • Reasonable accommodations during the recruitment process • Inclusive and accessible workplace

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