Trilogy

Medical writer

• Prepare a variety of clinical regulatory documents as the lead writer in collaboration with client authoring teams and other writers
• Ensure documents meet agreed timelines, project budgets, relevant SOPs, Trilogy requirements, and client requirements
• Provide document-specific advice to clients
• Oversee and coordinate other writers and QC specialists
• Project manage document timelines and review cycles
• Work in clients’ regulatory document management systems

Principal Medical Writer

• Function as a lead writer to prepare clinical regulatory documents, including Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, and scientific publications
• Collaborate with client authoring teams and other writers
• Ensure documents are produced according to agreed timelines, monitor and manage project budgets, adhere to relevant SOPs, and meet Trilogy and client requirements
• Provide document-specific advice to clients
• Oversee and coordinate writers and QC specialists assisting with assigned documents
• Project manage document timelines and review cycles
• Work in clients’ regulatory document management systems

Principal/Associate Principal Medical Writer

• Prepare clinical regulatory documents as lead writer, including Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in CTD format, Investigator Brochures, IMPDs/INDs, and scientific publications
• Collaborate with client authoring teams and other writers
• Produce documents according to agreed timelines and manage project budgets
• Adhere to relevant SOPs and meet Trilogy and client requirements
• Provide document-specific advice to clients
• Oversee and coordinate writers and QC specialists
• Project manage document timelines and review cycles
• Work in clients’ regulatory document management systems

Senior/Principal Medical Writer

• Prepare clinical regulatory documents including Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in CTD format, Investigator Brochures, IMPDs/INDs, and scientific publications as lead writer
• Collaborate with client authoring teams and other writers
• Ensure documents meet agreed timelines, project budgets, SOPs, Trilogy requirements, and client requirements
• Provide document-specific advice to clients
• Oversee and coordinate writers and QC specialists
• Project manage document timelines and review cycles
• Work in clients’ regulatory document management systems