Medical Writer I – Clinical Trial Transparency Specialist

This is a fully remote position, open to applicants in Poland.

📋 Description

• Oversee and coordinate the anonymization of datasets and documents according to scheduled timelines, adhering to Incyte's SOPs and regulatory standards.

• Collaborate effectively with the Biostatistics, Programming, and Medical Writing teams to gather and integrate necessary documents and datasets.

• Formulate anonymization strategies based on direct and indirect identifiers, assessing and reducing re-identification risks in compliance with GDPR guidelines.

• Process datasets and documents while implementing the required transformations.

• Contribute to Anonymization Reports that support the anonymization submissions for Health Canada and EMA policies.

• Ensure accurate and consistent redaction of clinical trial documents to comply with EU CTR, ClinicalTrials.gov, and Publications.

• Conduct quality checks on documents redacted/anonymized by other team members.

• Partner with Regulatory Operations to guarantee the publication of redacted documents in the Regulatory Document Management System.

• Aid in creating internal work instructions, training materials, and procedures as necessary to align with global requirements and Incyte's policies.

• Demonstrate the ability to work independently and troubleshoot issues effectively.

• Build and sustain collaborative relationships internally to foster effective and efficient working dynamics, ensuring the delivery of high-quality outputs.

• Remain updated on new global requirements for clinical trial disclosure and transparency.

⛳️ Requirements

• Bachelor's degree in a scientific or technical discipline.

• At least 3 years of professional experience in health sciences or related sectors (pharmaceutical, CRO, etc.).

• Proficient understanding of global regulatory guidelines related to clinical trial disclosure and transparency.

• Proven experience with global clinical trial disclosure processes and systems.

• Strong Excel and analytical capabilities, along with familiarity with SharePoint and/or document management systems.

• Excellent communication, organizational, time management, and project management abilities.

• Knowledge of ICH-GCP and awareness of clinical publication practices and standards (e.g., ICMJE).

🏝️ Benefits

• We are committed to nurturing our employees through career development and advancement opportunities.

• Supportive and engaged management team.

• Technical and therapeutic area training provided.

• Peer recognition and a comprehensive rewards program.

• Dedication to fostering an inclusive workplace culture.