Medical Writer (CTT)

Role & responsibilities: • Mentors less experienced medical writers on projects, as necessary. • Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision. • Develops or supports a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinical study reports; o Patient narratives; o Annual reports; o Investigator brochures. • Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. • Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. • Serves as peer reviewer on internal review team. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format. • Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget. • Performs on-line clinical literature searches, as applicable. • Working knowledge of drug development process and regulatory guidelines. • Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing. • Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership. • Completes required administrated tasks within the specified timeframes. • Performs other work-related duties as assigned.