Senior Medical Writer

Job not on LinkedIn

🔥 0 minutes ago

🇹🇼 Taiwan – Remote

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 10%

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Emerald Clinical

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2000

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Emerald Clinical is a leading global clinical research organization (CRO) founded in the Asia‑Pacific region that provides end‑to‑end clinical trial services to biopharmaceutical, medical device, and diagnostic companies. With about 25 years of experience and a team of 800+ operating across 40+ locations worldwide, Emerald Clinical manages trials across all phases including registration and post‑marketing studies, and offers clinical operations, project management, and trial staffing support. The company emphasizes scientific expertise, operational excellence, and global reach to support drug and device development.

📋 Description

• Research, write, and edit clinical documents, including clinical study reports, clinical study protocols, clinical plan outlines, regulatory submission document sections, and scientific manuscripts • Apply therapeutic expertise, clinical drug development knowledge, and relevant experience to products for human use • Act as Lead Medical Writer on complex projects, including regulatory submissions, CTD modules, and clinical overviews • Liaise independently with customers on medical writing issues • Propose costings for less routine projects, out-of-scope activities, and potential budget efficiencies • Present project-specific Medical Writing proposals at full-service bid defence meetings • Interpret non-clinical and clinical data in technical reports • Provide senior review and guidance for documents prepared by junior staff • Design training materials and contribute to generic training plans • Deliver general Medical Writing training to internal and external groups • Act as Project Manager for small series of stand-alone Medical Writing projects • Keep current with medical writing, regulatory knowledge, drug development trends, and advances • Propose SOP revisions and process improvements • Draft and review Medical Writing SOPs

🎯 Requirements

• A postgraduate degree from an accredited institution in Life Sciences or Health-related Sciences, or equivalent • 5–6 years of science or medical-related writing experience • 5–8 years of experience in a pharmaceutical company or CRO developing drugs for human use, including complex clinical trials and submission projects • Mastery of medical terminology and multiple therapeutic areas • Ability to guide others • Proficiency in document management systems, authoring tools, and collaboration platforms • Excellent written, oral communication, and presentation skills • Ability to lead client communications • Fluency in English reading, writing, and speaking • Ability to author highest-complexity English regulatory documents • Extensive experience in clinical study design and protocol development/writing • Experience leading pivotal trial protocols, such as Phase III • In-depth knowledge of regulatory submission requirements and ICH guidelines • Familiarity with multi-regional submission strategies, including FDA/NMPA

🏖️ Benefits

• Competitive compensation with a tailored salary and benefits package reflecting skills and experience • Hybrid or remote working arrangements, depending on location and role • Learning opportunities and access to a global network of scientific leaders • Employee wellbeing programs and initiatives promoting work-life balance, health, and team connection • Global engagement surveys • Recognition programs • Team-building events • Exposure to diverse projects and clients through international reach