Medical writer

• Lead development of high-quality, on-time clinical study documents
• Plan, write, edit, format, and perform QC review of clinical documents, including clinical study protocols, IBs, ICF templates, DSURs, CSRs, and CSR patient narratives
• Develop documents in compliance with Precision MW Style Guide, Precision SOPs, ICH, FDA, GCP, and eCTD requirements
• Manage documents from template through final approved version in collaboration with sponsors, external vendors, and internal Precision project teams/departments
• Independently formulate key messages from clinical study data
• Author complex content using knowledge of relevant processes
• Communicate clearly and concisely with internal and client teams
• Contribute to medical writing processes, SOPs, templates, and work instructions
• Perform literature-based research to support writing activities
• Perform other duties as assigned

Senior Medical Writer/Principal Medical Writer

• Lead the development of high-quality and on-time clinical study documents
• Plan, write, edit, format, and perform QC review of clinical documents, including clinical study protocols, IBs, ICF templates, DSURs, CSRs, and CSR patient narratives
• Develop documents in compliance with Precision MW Style Guide, Precision SOPs, applicable regulatory guidelines, and eCTD requirements
• Ensure smooth and effective document management from template through final approved version in collaboration with sponsors, external vendors, and internal Precision project teams/departments
• Independently formulate key messages from clinical study data
• Author complex content using knowledge, skills, and understanding of processes
• Communicate clearly and concisely in writing and verbally with internal and client teams
• Contribute to the development and maintenance of medical writing processes, SOPs, templates, and work instructions
• Perform literature-based research to support writing activities
• Perform other duties as assigned

Medical writer jobs in Romania

Senior Medical Writer/Principal Medical Writer

Senior Medical Writer / Principal Medical Writer