Medical Writer ; remote in Poland

Medical Writer I (remote), Poland Job Responsibilities

• The Clinical Trial Transparency Anonymization Specialist is responsible for processing the anonymization of clinical trial documents and datasets required for public disclosure.
• Partner with internal and external collaborators on planning, initiation, and delivery of anonymized documents and datasets in support of the EU Clinical Trial Regulation (EU CTR), Clinical Trials.gov, and publications and regulatory authority transparency submissions (e.g., EMA Policy 0070, Health Canada PRCI).
• Perform anonymization tasks using the latest technologies available and following industry best practices in line with company principles, policies, standards, and applicable law.

• Manage and facilitate anonymization of datasets and documents against planned timelines, in accordance with SOPs and regulatory requirements.
• Assess documents in-scope for public disclosure according to EMA Policy 0070 and Health Canada PRCI.
• Work closely with Biostatistics, Programming, 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 Health Canada and EMA policies.
• Ensure accurate and consistent redaction of clinical trial documents to support EU CTR, Clinical Trials.gov, and publications.
• Quality‑check documents redacted or anonymized by other team members.
• Collaborate with Regulatory Operations to ensure the publishing of redacted documents in the Regulatory Document Management System.
• Use technology tools for the 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 company policies.
• Work with minimal supervision and resolve issues independently.
• 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.

• Bachelor’s degree in a scientific or technical field.
• Minimum three years of work experience in the health sciences or related industries (pharmaceutical, CRO, etc.).
• Working knowledge of global regulatory guidelines pertaining to clinical trial disclosure and transparency.
• Demonstrated experience with global clinical trial disclosure and transparency processes and systems.
• Demonstrated Excel and analytical skills, with working knowledge of SharePoint and/or document management systems.
• Strong communication, organizational, time‑management, and project‑management skills.
• Knowledge of ICH-GCP and awareness of clinical publication practices and standards (e.g., ICMJE).

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations. The Company strives to adhere to the EU Equality Directive and applies policy regarding the recruitment and employment of its employees worldwide.