We are looking for a Medical Writer I to support the preparation, review, and delivery of clinical and regulatory documents. The ideal candidate will have a strong scientific background, excellent writing skills, and an understanding of clinical research and drug development processes.
Author, edit, and review clinical and regulatory documents, including: Clinical Study Reports (CSRs), Interim Study Reports, Informed Consent Forms (ICFs), Safety Update Reports, Patient Narratives
Conduct literature searches and scientific reviews to support document development.
Analyze and interpret clinical study data to prepare high-quality scientific content.
Ensure compliance with ICH-GCP guidelines, SOPs, templates, and regulatory requirements.
Perform quality checks to ensure data accuracy, consistency, and document integrity.
Collaborate with cross-functional teams including Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, and Medical Affairs.
Support document review cycles, manage timelines, and address stakeholder feedback.
