Medical Writer / Senior Medical Writer

About This Role

This role involves researching, writing, and editing clinical documents such as clinical study reports, protocols, and regulatory submission sections. The successful candidate will apply therapeutic expertise and clinical drug development knowledge to create documentation for drugs, biologics, and devices for human use. The position may also provide writing support for more complex clinical documentation and serve as a primary technical contact with clients.

Responsibilities

• Act as Lead Medical Writer on the most complex projects (e.g., regulatory submissions, CTD modules, clinical overviews)
• Independently 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 MW proposals at full-service bid defence meetings, with management input to slides as required
• Interpret non-clinical and clinical data in the preparation of various technical reports
• Provide senior review and guidance for most documents prepared by junior staff
• Design training materials; input into generic training plans; may deliver general Medical Writing training to internal and external groups
• Act as Project Manager for a small series of stand-alone Medical Writing projects (e.g., series of related CSRs)
• Keep abreast of current data, trends, medical writing/regulatory knowledge, developments and advances in drug development/medical writing
• Propose revisions to SOPs or suggest process improvements; may draft new MW SOPs for review; act as reviewer for MW SOPs as assigned

Requirements

• 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
• Proficient 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 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; familiar with multi-regional submission strategies (FDA/NMPA)

Benefits

• Tailored benefits package