[Hiring] Regulatory Technician @ICON plc

Role Description

As a Regulatory Technician you will work with the Clinical Trials Information System (CTIS), and will also provide support for submissions and other documents by performing necessary tasks including assembly, dispatch among others and coordinating resources for submissions.

• Proactively identify and mitigate risks through CTIS helpdesks regarding data/document management and upload to CTIS and liaise with internal/external stakeholders to resolve.
• Actively maintain applicable study-level account access for assigned projects for CTIS to maintain compliance and confidentiality.
• Collaborate with key stakeholders to manage and perform data entry and document upload.
• Monitor CTIS notifying applicable stakeholders of activities for their action and subsequent follow up.
• Create files documenting submissions completed through CTIS, conclusions, decisions and any other communication provided via CTIS.
• Perform Quality Control review in accordance with applicable process.
• Maintain agreed timelines.
• Ensure project-specific training is completed on time, as applicable.

Qualifications

• 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.

Requirements

• Employment with ICON is contingent upon having the 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.
• Benefits may vary depending on role and location.

Company Description

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.