Medical Writer - Clinical Trial Transparency Specialist - Poland; Sponsor-dedicated

Medical Writer I – Clinical Trial Transparency Specialist – Poland (Sponsor‑dedicated)

Responsible for managing and facilitating anonymization of datasets and clinical trial documents in compliance with regulatory requirements, GDPR, and sponsor policies.

• Manage and facilitate anonymization of datasets and documents against planned timelines, following SOPs and regulatory requirements.
• Collaborate with Biostatistics, Programming, and Medical Writing teams to identify and assimilate required documents and datasets.
• Develop anonymization plans assessing direct and indirect identifiers and mitigate re‑identification risk per GDPR guidance.
• Process datasets and documents, applying required transformations and ensuring accurate redaction of clinical trial documents for EU CTR, Clinical Trials.gov, and publications.
• Perform quality checks on documents redacted or anonymized by other team members.
• Collaborate with Regulatory Operations to ensure publication of redacted documents in the Regulatory Document Management System.
• Use technology tools for delivery of anonymized clinical documents.
• Assist in developing internal work instructions, training materials, and procedures to comply with global requirements and company policies.
• Maintain collaborative relationships internally to ensure effective delivery of high‑quality deliverables.
• Stay informed of new clinical trial disclosure and transparency requirements globally.

• Bachelor’s degree in a scientific or technical field.
• Minimum of 3 years of experience in health sciences or related industries (pharmaceutical, CRO, etc.).
• Knowledge of global regulatory guidelines pertaining to clinical trial disclosure and transparency.
• Demonstrated experience in global clinical trial disclosure and transparency processes and systems.
• Strong 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 and awareness of clinical publication practices and standards (e.g., ICMJE).

The Company is an equal opportunity employer and is committed to compliance with the EU Equality Directive and the Americans with Disabilities Act, including provision of reasonable accommodations to assist employees or applicants in performing essential functions of the job.