Medical Writer / Senior Medical Writer (Taiwan)
Emerald Clinical · Kaohsiung
Job description
About the role
The Medical Writer / Senior Medical Writer will research, write, and edit a range of clinical documents, including study reports, protocols, regulatory submission sections, and scientific manuscripts. You will apply therapeutic expertise and drug development knowledge to support the creation of high‑quality documentation for drugs, biologics, devices and other human‑use products.
Key responsibilities
- Lead medical writing on complex projects such as regulatory submissions, CTD modules and clinical overviews.
- Interact directly with clients to address medical writing issues and present cost proposals.
- Interpret non‑clinical and clinical data to prepare technical reports and senior‑review junior staff documents.
- Develop training materials and deliver medical writing training to internal and external audiences.
- Act as project manager for small series of stand‑alone medical writing projects.
Required profile
- Post‑graduate degree in Life Sciences or Health‑related field.
- Minimum 3 years of scientific or medical writing experience, including 2 years in a pharmaceutical company or CRO.
- Proven experience in clinical study design, protocol development and pivotal trial documentation.
- Strong knowledge of ICH guidelines and multi‑regional regulatory submission strategies (FDA, NMPA).
Required skills
- Proficiency with document management systems, authoring tools and collaboration platforms.
- Mastery of medical terminology across multiple therapeutic areas.
What we offer
- Competitive salary and benefits package.
- Hybrid or remote working arrangements.
- Access to global learning opportunities and career growth programs.
- Employee wellbeing initiatives and team‑building events.
- Opportunities to work on international clinical research projects.
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Published 3 weeks ago
Expires 1 month from now
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Emerald Clinical
Kaohsiung
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