[Hiring] Disclosure Specialist @ICON plc

Role Description

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.

Qualifications

• 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.

Requirements

• Diplôme universitaire (Bac+3 minimum) en sciences requis ; un diplôme supérieur est un atout.
• 3 à 5 ans d’expérience minimum dans un environnement clinique ; une expérience dans les processus cliniques/réglementaires ou dans l’industrie pharmaceutique est indispensable.
• Connaissance des lignes directrices ICH et GCP requise.
• Excellentes compétences en communication orale et écrite.
• Expérience internationale dans les études cliniques appréciée.
• Orientation client démontrée, avec un haut niveau de satisfaction client.
• Capacité à prioriser et gérer plusieurs tâches simultanément.
• Sens du détail, esprit logique, capacité d’analyse critique et de résolution de problèmes.
• Bon jugement, autonomie dans la prise de décision et sens aigu du suivi.
• Capacité à collaborer avec plusieurs équipes d’étude dans une ou plusieurs aires thérapeutiques.
• Maîtrise des outils informatiques requise.

Benefits

• 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.