Medical Writer – Senior Medical Writer

This is a fully remote position, open to applicants in Taiwan.

📋 Description

• Conduct research, compose, and refine clinical documents, which include clinical study reports, study protocols, clinical plan outlines, sections for regulatory submissions, and scientific manuscripts.

• Utilize therapeutic knowledge, clinical drug development expertise, and relevant experience on projects involving pharmaceuticals, biologics, devices, and other human-use products.

• Serve as the Lead Medical Writer on intricate projects such as regulatory submissions, Common Technical Document (CTD) modules, and clinical overviews.

• Communicate directly with clients regarding medical writing matters.

• Suggest cost estimates for less standard projects, out-of-scope tasks, and prospective budget efficiencies, with the guidance of a manager.

• Present project-specific medical writing proposals during full-service bid defense meetings.

• Analyze non-clinical and clinical data within technical reports.

• Offer senior-level review and mentorship for documents created by junior personnel.

• Create training materials and contribute to overarching training plans.

• Deliver general Medical Writing training sessions to both internal and external audiences.

• Function as Project Manager for a small series of standalone Medical Writing projects.

• Keep abreast of current data, trends, medical writing, regulatory knowledge, and advancements in drug development.

• Recommend revisions to Standard Operating Procedures (SOPs) and process enhancements; draft and review Medical Writing SOPs.

⛳️ Requirements

• A postgraduate degree from an accredited institution in Life Sciences or Health-related Sciences, or equivalent qualifications.

• Over 3 years of experience in science or medical writing.

• Proficient in medical terminology across multiple therapeutic areas; capable of guiding others.

• Skilled in document management systems, authoring tools, and collaboration platforms.

• Exceptional written and oral communication skills, including presentation abilities; capable of leading client communications.

• Fluent in English, both written and spoken; adept at creating highly complex English regulatory documents.

• At least 2 years of experience in a pharmaceutical company or Contract Research Organization (CRO) developing drugs for human use, with involvement in complex clinical trials and submission projects.

• Extensive experience in clinical study design and protocol development/writing; led pivotal trial protocols (e.g., Phase III).

• Comprehensive understanding of regulatory submission requirements and ICH guidelines.

• Knowledgeable about multi-regional submission strategies (FDA/NMPA).

🏝️ Benefits

• Competitive compensation: customized salary and benefits package that reflects skills and experience.

• Options for hybrid or remote working arrangements, based on location and role.

• Opportunities for learning and access to a global network of scientific leaders.

• Employee wellbeing programs and initiatives that promote work-life balance, health, and team cohesion.

• Global engagement surveys.

• Recognition programs.

• Team-building events.

• Opportunities to work on diverse international projects and collaborate with various clients.