Senior Medical Writer - Regulatory

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: clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; 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. 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. Works to improve patients’ lives around the world.