Disclosure Specialist

Disclosure Specialist

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.

This role supports clinical trial transparency and disclosure activities, including document redaction, results posting, and plain language summary development, in compliance with global regulations and client SOPs. The position ensures accurate, compliant public release of clinical trial information through close collaboration with cross-functional teams.

What you will be doing:

• Support the client’s clinical trial transparency processes in compliance with trial transparency laws and requirements and client policies.

• Possesses a working knowledge of FDAAA (Food and Drug Administration Amendments Act of 2007) and EMA clinical trial Directive 2001/20/EC compliance and client SOPs.

• Attends and assists with DISCLOSURE related meetings

• Supports trial transparency processes. Responsibilities may include any of the following:

• Reviews and prepares documents to ensure personal protected information (PPI) is removed

• Works collaboratively with contributing authors and product development teams to identify commercially confidential information (CCI) in documents for public disclosure

• Executes the preparation, quality check and team review of clinical documents for public release including the completion of the justification table for CCI redactions

• Assists with results and registration process tasks as needed

• Supports the integration of acquired clinical trials to ensure that trial information posted on ClinicalTrials.gov and EudraCT can be located in the client’s local data and document systems

• Assists with plain language summary operations as needed

• Develops tools to support the tracking of PLS deliverables (including tracking and metrics)

• Collaborates with PLS team in the development and maintenance of plain language structured content and graphics libraries

• Provides support in maintaining the Health Literate Glossary

• Participates in user acceptance testing (UAT) testing, document/data management/clean-up projects, audit preparation and participation when applicable

• Assures management is informed of any problems or unresolved issues that could affect the timely completion of work or the quality of work.

• Performs other duties as assigned.

Your profile:

• Minimum Bachelor's Degree with a science background required; advanced degree preferred

• Minimum 3-5 years of experience working in a clinical setting; clinical/regulatory process experience or in a pharmaceutical environment a must

• Knowledge of ICH and GCP guidelines required

• Good communication skills, both oral and written are mandatory

• International study experience a plus

• Demonstrated ability to be customer-oriented in order to achieve high customer satisfaction levels

• Demonstrated ability to prioritize and manage multiple tasks

• Ability to attend to detail, think logically and to critically evaluate and solve problems

• Demonstrated good judgmental and independent decision-making abilities, as well as strong follow- up skills

• Ability to work with multiple study teams in one or more therapeutic areas

• Computer literacy required

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