Medical Writer – Senior Medical Writer
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Job Description
Medical Writer leading complex clinical and regulatory documentation for Emerald Clinical Trials. Supporting drug development and clinical research across global pharmaceutical and biotech programs.
Responsibilities:
- 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:
- 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:
- 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
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