Trilogy

Medical writer

• Function as a lead writer to prepare a variety of clinical regulatory documents (Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications)
• Collaborate with members of client authoring teams and be supported by other writers as appropriate
• Ensure documents are produced according to agreed timelines and adhere to relevant SOPs
• Monitor and manage project budgets and meet client requirements
• Provide document-specific advice to clients
• Oversee and coordinate other writers and QC specialists assisting with documents under your responsibility
• Project manage the timelines and review cycles of your documents
• Work in the client’s regulatory document management systems
• Serve as an integral member of clinical development teams supporting writing and coordination across therapeutic areas

Associate Principal / Principal Medical Writer