Medical Writer
Core
Primary author of clinical study reports, study protocols, and complex regulatory documents (IBs, INDs, MAAs) for internal and external clients in the pharmaceutical industry.
Role type
Medical Writer
Builds
Clinical study reports, study protocols, Investigational Brochures (IBs), Investigational New Drug applications (INDs), Marketing Authorization Applications (MAAs)
Domain
Pharmaceutical / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical writing, regulatory documentation knowledge, drug development process knowledge, data interpretation, document management systems proficiency
Preferred skills
Pharmaceutical/CRO industry experience, scientific writing experience
Technologies
Document management systems, Excel, Outlook
Responsibilities
Write and provide input on routine clinical documents, assist with complex regulatory documents, ensure compliance with quality processes, assist in program management activities, represent the department at project meetings
