Medical Writer – Senior Medical Writer

Emerald Clinical

. Research, write, and edit clinical documents, including clinical study reports, clinical study protocols, clinical plan outlines, regulatory submission document sections, and scientific manuscripts .

Posted 9/17/2026full-timeRemote • TaiwanSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Medical Writing, including the development of clinical documents and regulatory submissions, while effectively leading projects and training initiatives. Proficient in interpreting clinical data and guiding junior staff in a pharmaceutical or CRO environment.

Highest-signal resume keywords

Medical Writing ExpertiseRegulatory Submission KnowledgeClinical Study DesignDocument Management Systems ProficiencyFluent English Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study Report WritingClinical Protocol DevelopmentRegulatory Submission Document PreparationTherapeutic Area MasteryClinical Data InterpretationSOP Drafting and ReviewProject ManagementTraining Material DesignComplex Clinical Trial ExperienceICH Guidelines Knowledge

Soft Skills

Excellent Communication SkillsPresentation SkillsClient LiaisonLeadership in TrainingGuidance for Junior Staff

Tools & Technologies

Document Management SystemsAuthoring ToolsCollaboration Platforms

Industry Keywords

Pharmaceutical IndustryCRO ExperienceMulti-Regional Submission StrategiesFDA/NMPA RegulationsLife Sciences Degree

About the role

Key responsibilities & impact

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 projects involving drugs, biologics, devices, and other products for human use
Act as Lead Medical Writer on complex projects such as regulatory submissions, CTD modules, and clinical overviews
Liaise directly with customers on medical writing issues
Propose costings for less routine projects, out-of-scope activities, and potential budget efficiencies with manager guidance
Present on 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
Monitor current data, trends, medical writing and regulatory knowledge, and drug development advances
Propose SOP revisions and process improvements; draft and review Medical Writing SOPs

Requirements

What you’ll need

A post graduate degree from an accredited institution in Life Sciences or Health-related Sciences, or equivalent
3+ years of science or medical related writing experience
Mastery of medical terminology and multiple therapeutic areas; able to guide others
Proficiency in document management systems, authoring tools, and collaboration platforms
Excellent written, oral communication and presentation skills; able to lead client communications
Fluent in English reading, writing, and speaking; able to author highest complexity English regulatory documents
2+ years of experience in a pharmaceutical company or CRO developing drugs for human use, including complex clinical trials and submission projects
Extensive experience in clinical study design and protocol development/writing; led pivotal trial (e.g., Phase III) protocols
In-depth knowledge of regulatory submission requirements and ICH guidelines
Familiarity with multi-regional submission strategies (FDA/NMPA)

Benefits

Comp & perks

Competitive compensation: 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 supporting work-life balance, health, and team connection
Global engagement surveys
Recognition programs
Team-building events
Exposure to diverse international projects and clients