Senior Regulatory Technician

Senior Regulatory Technician

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.

What you will be doing?

• Collaborate with key stakeholders to manage and complete data entry and document upload to and monitoring of Clinical Trial Regulatory systems/portals according to study specifics, ICON policies, procedures, applicable regulations and the principles of ICH-GCP with in line with contractual agreement

• Support Regulatory submissions and deliverables to meet department and project goals

• Depending upon experience, become involved, when required, staff training/mentoring and contribute to the review of ICON systems and procedures as appropriate

• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs

• Ensure Regulatory deliverables are performed in accordance with all relevant regulations, guidelines, policies and procedures within contractual timelines and budget

• Thorough knowledge of ICON’s SOPs/WIs, ICH, GCP, appropriate regulations and guidance

• Thorough knowledge of ICON systems applicable to role

• Proactively identify and mitigate risks through Regulatory Agency helpdesks or internal sources, regarding data/document management and upload to Clinical Trial Regulatory systems/portals and liaise with internal/external stakeholders to resolve

• Actively maintain applicable study-level account access for assigned projects for Clinical Trial Regulatory systems/portals to maintain compliance and confidentiality

• Collaborate with key stakeholders to manage and perform data entry and document upload to required country/regional Regulatory systems/portals using the data and documents provided by project team

• Monitor Clinical Trial Regulatory systems/portals for notices and alerts and notifying applicable stakeholders of activities for their action and subsequent follow up

• Create files documenting submissions completed through country/regional Clinical Trial Regulatory systems/portals, conclusions, decisions and any other communication provided via Clinical Trial Regulatory systems/portals

• Perform Quality Control review in accordance with applicable process

• Maintain agreed timelines

• Support other Regulatory deliverables under the direction of leadership, as required

• Travel (approximately 5%) domestic and /or international

Your profile

• Minimum of 3 years’ relevant experience

• Read, write and speak fluent English

• Proficient in using applicable business applications

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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