Regulatory Technician

hace 2 semanas

Ciudad de México ICON Plc A tiempo completo

Regulatory Technician - Mexico City only - Office based role (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

Regulatory Technician

Mexico City only - Office based role (Hybrid)

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,

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:

- Mandatory advanced English (speak, read, write)
- Ideally you will have 1-2 years relevant experience within clinical research or have knowledge of clinical terminology and documentation
- Ability to work independently
- Experience with regulatory submissions and CTIS is a differential but not mandatory

LI-ED1

LI-Hybrid

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, 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 assurance- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Visit our

careers site

to read more about the benefits ICON offers.

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