Senior Medical Writer (Taiwan)

About the role

Emerald Clinical Trials is seeking a Senior Medical Writer to lead the creation and editing of clinical documents for drug, biologic, and device development in Taiwan. The role involves applying therapeutic expertise and clinical development knowledge to produce high‑quality regulatory and scientific deliverables.

Key responsibilities

• Act as Lead Medical Writer on complex projects such as regulatory submissions, CTD modules, and clinical overviews.
• Liaise directly with clients on medical writing issues and present cost proposals.
• Interpret non‑clinical and clinical data to prepare technical reports, CSRs, protocols, and scientific manuscripts.
• Provide senior review and guidance to junior writers and design training materials.
• May serve as Project Manager for small series of stand‑alone medical writing projects.
• Contribute to SOP revisions, process improvements, and draft new medical writing SOPs.

Required profile

• Post‑graduate degree in Life Sciences, Health‑related Sciences, or a related field.
• Extensive experience in medical writing, regulatory documentation, and clinical study report preparation.
• Proven ability to work independently and manage client relationships.
• Strong knowledge of drug development processes and regulatory requirements.

Required skills

• Medical writing
• Regulatory submission documentation
• Clinical study report (CSR) preparation
• Clinical protocol development
• Data interpretation of non‑clinical and clinical studies