MMS is seeking a Senior Medical Writer to critically evaluate, analyze, and interpret medical literature, and write and edit clinical development documents. The ideal candidate has 3+ years of industry regulatory writing experience and a degree in a scientific or medical discipline.
Requirements
- At least 3 years of previous experience in the pharmaceutical industry
- Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience
- Bachelor's, Master's, or Ph.D. in scientific, medical, clinical discipline
- Substantial clinical study protocol experience as lead author
- Experience leading and managing teams while authoring regulatory documents with aggressive timelines
- Experience in regulatory submissions presented to regulatory authorities a plus
- Understanding of clinical data
- Exceptional writing skills
- Excellent organizational skills and ability to multi-task
- Expert in MS Word, Excel, PowerPoint, and related word processing tools
- Experience as project lead or managing a project team
- Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus