Medical writer

• 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 Programing 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.
• Assist in the development of internal work instructions, training materials, and procedures as needed to comply with global requirements and Incyte policies.
• Ability to work with minimum supervision and resolve issues.
• Develop and maintain collaborative relationships internally to ensure effective and efficient working relationships and the delivery of high quality deliverables.
• Stay informed of new clinical trial disclosure and transparency requirements globally, including but not limited to clinical trial registration and posting of results.

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