Senior Regulatory Technician

Hybrid

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Senior Regulatory Technician

Location: Office based role (Hybrid)

As a   Senior 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.

Responsibilities:

• 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

To succeed you will need:

• Minimum 3 years of  relevant experience within clinical research and have knowledge of clinical terminology and documentation

• Advanced expertise of applicable Clinical Trial Regulatory system/portal

• Mandatory advanced  English (speak, read, write)

• Ability to work independently

• Experience with regulatory submissions and CTIS is a differential but not mandatory

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What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply