Study Review Specialist I

Study Review Specialist I - Mexico City only

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

Study Review Specialist I

Location: Mexico (Office Based in Mexico City only)

As a Study Review Specialist I you will be responsible for reviewing and approve global Critical Package Documents (CDPs) prior to IP release in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines and the principles of ICH/GCP, ensuring the highest quality and accuracy of documentation.

What You Will Be Doing:

Perform timely and accurate task progress communication and data entry of all relevant CDP Review and Approval activities into the appropriate tracking system.

Ensure CDP approval dates are reflected accurately in ICON’s systems and are achieved in the required turnaround timelines

Conduct internal quality review of packs (parallel reviews) or TMF, where assigned.

Work with key stakeholders to optimize performance and collaborate to ensure successful project outcomes

Assume responsibility as Subject Matter Expert (SME) for the required topics, ensuring knowledgeable and updated in any changing regulatory requirements.

Attending study team meetings as required

Support other teams across VAST with additional tasks, where required

What you need to succeed in the role:

Bachelor’s Degree preferably in Life Sciences

Fluency in English is a MUST (reading, writing, speaking)

Minimum of 1 years’ experience and understanding of Site Regulatory Package / Critical Package Documents (CDPs) requirements and activities.

Knowledge of local and/or international regulatory processes, including submissions to regulatory authorities and ethics committees.

Ability to read and understand clinical protocols, regulatory documents, and study-specific processes.

Strong attention to detail and organizational skills.

Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment.

#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.

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

JR131666