Medical writer

• 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) as the lead writer in collaboration with members of client authoring teams and supported by other writers, as appropriate
• Ensure that all documents are produced according to agreed timelines, monitor and manage project budgets, adhere to relevant SOPs, and meet the requirements of Trilogy as well as the company’s clients
• Be responsible for providing document-specific advice to clients
• Oversee and coordinate other writers and QC specialists assisting on documents under your responsibility
• Project manage the timelines and review cycles of your documents
• Work in the client’s regulatory document management systems

Associate/Principal Medical Writer

Senior Analyst – Senior Medical Writer, Medical Communications