Senior Medical Writer

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

📋 Description

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

• Utilize therapeutic expertise, knowledge of clinical drug development, and relevant experience for products intended for human use.

• Serve as the Lead Medical Writer on intricate projects, including regulatory submissions, CTD modules, and clinical overviews.

• Independently communicate with clients regarding medical writing matters.

• Suggest cost estimates for less routine projects, out-of-scope tasks, and potential budget optimizations.

• Present tailored Medical Writing proposals during comprehensive bid defense meetings.

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

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

• Create training materials and contribute to the development of generic training programs.

• Facilitate general Medical Writing training for both internal and external audiences.

• Assume the role of Project Manager for a small series of independent Medical Writing projects.

• Stay updated on trends in medical writing, regulatory standards, drug development, and advancements.

• Recommend revisions to SOPs and process enhancements.

• Draft and evaluate Medical Writing SOPs.

⛳️ Requirements

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

• 5–6 years of experience in scientific or medical writing.

• 5–8 years of experience within a pharmaceutical company or CRO focused on drug development for human use, including complex clinical trials and submission projects.

• Proficiency in medical terminology across various therapeutic areas.

• Capability to guide and mentor others.

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

• Exceptional written, verbal communication, and presentation abilities.

• Proficient in leading client communications.

• Fluent in English, with reading, writing, and speaking skills.

• Competence in drafting the highest-complexity English regulatory documents.

• Extensive experience in the design of clinical studies and the development/writing of protocols.

• Background in leading pivotal trial protocols, such as Phase III.

• Thorough understanding of regulatory submission criteria and ICH guidelines.

• Familiar with multi-regional submission strategies, including FDA/NMPA.

🏝️ Benefits

• Competitive compensation with a personalized salary and benefits package reflecting skills and experience.

• Flexible hybrid or remote working arrangements, depending on location and position.

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

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

• Global engagement surveys.

• Recognition programs.

• Team-building events.

• Exposure to a variety of projects and clients through international outreach.