Medical writer

• 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 including clinical study protocols and clinical study protocol amendments, clinical study reports, patient narratives, annual reports, and 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, addressing team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format
• Adheres to established regulatory standards, including ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and 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
• Minimal travel may be required (less than 25%)

Medical Writer II – CSR Narratives

Medical Writer II – Funding e-Request

Senior Medical Writer