Senior Medical Writer – Clinical Documentation (Taiwan)

About the role

Emerald Clinical Trials is seeking an experienced Medical Writer to lead the creation and editing of complex clinical documents for drug, biologic and device programs in Taiwan. The role involves translating clinical data into regulatory submissions, study reports and scientific manuscripts while ensuring scientific accuracy and compliance.

Key responsibilities

• Act as Lead Medical Writer on 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 and senior‑review junior staff documents.
• Design and deliver training materials on medical writing best practices.
• Manage small groups of stand‑alone medical writing projects and propose SOP improvements.

Required profile

• Post‑graduate degree in Life Sciences or Health‑related field.
• Minimum 3 years of scientific/medical writing experience and at least 2 years in a pharmaceutical company or CRO.
• Extensive experience in clinical study design, protocol development and pivotal Phase III trials.
• Deep knowledge of ICH guidelines and multi‑regional regulatory submission strategies (FDA, NMPA).
• Fluent in English (reading, writing, speaking) for high‑complexity regulatory documents.

Required skills

• Proficiency with document‑management systems.
• Experience using authoring tools and collaboration platforms.
• Mastery of medical terminology across multiple therapeutic areas.
• Strong understanding of regulatory submission requirements and SOP development.

What we offer

• Competitive salary and benefits package.
• Hybrid or remote working flexibility.
• Access to global learning opportunities and career growth.
• Employee wellbeing programs and team‑building initiatives.