Role Description As a Clinical Trial Transparency Associate at ICON, you will be responsible for processing the anonymization of clinical trial documents and datasets required for public disclosure. The Anonymization Specialist will partner with internal and external collaborators on the planning, initiation, and delivery of anonymized documents and datasets in support of the EU Clinical Trial Regulation (EU CTR), ClinicalTrials.gov, and Publications and Regulatory Authority Transparency Submissions (e.g., EMA Policy 0070, Health Canada PRCI), manuscript publications, and data sharing. - Manage and facilitate anonymization of datasets and documents against planned timelines, in accordance with Incyte SOPs and regulatory requirements. - Assess documents in-scope for public disclosure according to EMA Policy 0070 and Health Canada PRCI. - Work closely with Biostatistics and Programming groups and Medical Writing teams to identify and assimilate the required documents and datasets. - Develop anonymization plans based on direct and indirect identifiers by measuring and mitigating re-identification risk according to GDPR guidance. - Process datasets and documents and apply required transformations. - Contribute to Anonymization Reports to support anonymization packages for policies of Health Canada and EMA. - Ensure accurate and consistent redaction of clinical trial documents to support EU CTR, ClinicalTrials.gov, and Publications. - Quality check of documents redacted/anonymized by other team members. - Collaborate with Regulatory Operations to ensure the publishing of redacted documents in the Regulatory Document Management System. - Experience with the use of Technology Tools for delivery of Anonymized Clinical Documents. Qualifications - Bachelor’s degree in a scientific or technical field. - Experience with documents anonymization and clinical trial transparency. - Minimum 3 years of work experience in either the health sciences or related industries (pharmaceutical, CRO, etc.). - Working knowledge of the global regulatory guidelines pertaining to clinical trial disclosure and transparency. - Demonstrated experience in global clinical trial disclosure and transparency processes and systems. - Demonstrated Excel and analytical skills, working knowledge of SharePoint and/or document management systems. - Strong communication, organizational, time management, and project management skills. - Knowledge of ICH-GCP, awareness of clinical publication practices and standards (ie, ICMJE). 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.

• leading the development of high-quality and on-time clinical study documents • planning, writing, editing, formatting, and QC review of clinical documents including clinical study protocols, IBs, ICF templates, DSURs, CSRs • ensures smooth and effective document management in collaboration with Sponsor, external vendors, and/or internal project teams • independently formulate key messages from clinical study data • author complex content using knowledge/skills and understanding of processes • communicate clearly and concisely both in writing and verbally with internal and client teams • contribute to the development and maintenance of medical writing processes, SOPs, templates, and work instructions

• Lead the development of high-quality and on-time clinical study documents • Clinical document planning, writing, editing/formatting, and performing QC review • Develops documents in compliance with Precision MW Style Guide, Precision SOPs, applicable regulatory guidelines (ie, ICH, FDA, GCP) and eCTD requirements • Ensure smooth and effective document management from start to finish (ie, from template to final, approved version) in collaboration with Sponsor, external vendors, and/or internal Precision project teams/departments • Ability to independently formulate key messages from clinical study data • Contributes to the development and maintenance of medical writing processes, SOPs, templates, and work instructions for key documents • Performing literature-based research to support writing activities

• Responsible for reviewing medical records to facilitate and obtain appropriate physician documentation for any clinical conditions or procedures to support the appropriate severity of illness, expected risk of mortality, and complexity of care of the patient • Completes initial medical records reviews of patient records within 24-48 hours of admission for a specified patient population • Conducts follow-up reviews of patients every 24-48 hours or as needed up through discharge • Formulate physician queries regarding missing, unclear, or conflicting health record documentation • Collaborates with providers, case managers, nursing staff and other ancillary staff regarding documentation • Communicates/Completes Clinical Documentation Integrity (CDI) activities and coding issues • Assists with Provider education, rounding and communication regarding open queries for resolution • Stays current with AHA Official Coding and Reporting Guidelines, CMS and other agency directives for ICD10-CM and PCS coding • Attends CDI Boot camp, CDI/coding trainings annually and quarterly