Medical Writer/Consultant

1. Write and edit clinical and regulatory documents, including Investigator’s Brochure (IB), clinical study protocols, Informed Consent Forms (ICF), and patient narratives. 2. Ensure compliance with ICH-GCP, FDA, and EMA regulatory standards. 3. Collaborate with cross-functional teams (clinical, regulatory, biostatistics) to ensure accuracy and clarity of content. 4. Support clinical study report (CSR) and regulatory submission document preparation (e.g., IND, NDA, BLA).