Job Summary
A medical device manufacturer is filling a position for a Remote Senior Clinical Medical Writer.
Core Responsibilities Include:
- Researching, preparing, writing, editing, and reviewing clinical evidence documents
- Conducting proofreading, editing, document formatting, and review comment integration activities
- Supporting regulatory approval process
Position Requirements Include:
- Education/experience equivalent to a Bachelor's in the medical, biological, physical or engineering disciplines
- 5 years of medical writing experience
- Proficient in searching medical literature and databases for clinical and technical information
- Extensive knowledge of regulatory requirements relative to Clinical Evaluation Reports
- Knowledge of U.S. FDA regulations and the Medical Devices Directive
- Ability to read, analyze, and interpret regulations, and technical standards
