Regulatory Technician

Warszawa, mazowieckie
Stała
Pełny etat

1 miesiąc temu

Regulatory TechnicianICON 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 developmentRegulatory TechnicianAs a Regulatory Technician you will be collaborating 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. You will also support regulatory submissions and deliverables to meet department and project goals.Duties and Responsibilities

Recognize, exemplify and adhere to ICON's values which centre around our commitment to People, Clients and Performance
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
Knowledge of ICON’s SOPs/WIs, ICH, GCP, appropriate regulations and guidance
Knowledge of ICON systems applicable to role
Proficient in using applicable business applications
Successfully complete internal/external training for applicable Clinical Trial Regulatory system/portal to complete Regulatory submissions
Standard expertise of applicable Clinical Trial Regulatory system/portal
Proactively identify and mitigate risks through Regulatory Authority 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 Clinical Trial 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 Regulatory systems/portals, conclusions, decisions and any other communication provided via 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
Ensure project-specific training is completed on time, as applicable
Travel (approximately 5%) domestic and /or international

Read and Write fluent English.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 entitlementsA 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.Life assuranceFlexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.Visit our 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 .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 to apply

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