Medical Writer BG Medicine

Responsibilities:

Research, write, edit Protocols, Investigator Brochures, Clinical Study Reports, Clinical summaries and other clinical/regulatory documents
Drive document preparation activities, manage review cycles, incorporate comments
Prepare and maintain timelines for medical writing projects
Reviews statistical analysis plans and clinical data reports to ensure consistent data reporting within a program and/ or therapeutic area
Familiar with work in accordance with Federal Regulations, Good Clinical Practices and BGMs Standard Operation Procedures
Read and interpret grant applications and the information to create documentation
Attends project launch and project update meetings
Research, write, edit Protocols, Investigator Brochures, Clinical Study QC documents


Requirements:

Advanced scientific degree preferred (MS )
Minimum of 5-plus years medical writing experience
Excellent written & oral communication skills
Excellent project management, interpersonal & meeting skills
Skilled in clinical data analysis
Advanced computer skills
Experience with templates and document management systems.

Location:	610 North Lincoln Street Waltham, MA 02451 United States