The Clinical Sciences Technical Writing Specialist works closely with Medical Affairs, Principal Investigators and statisticians to develop clinical documents. He / she may present or assist with preparing responses to regulators or present data to data monitoring committees, investigators, etc.
The Clinical Sciences Technical Writing Specialist serves a medical research function and applies a broad knowledge of clinical research activity, therapeutic area knowledge and regulatory requirements to facilitate the development and implementation of clinical studies. The primary objective and purpose of this position is ensuring that clinical trial protocols and study reports are developed and written with scientific rigor. He / she is responsible for all aspects of clinical science technical writing including researching, developing and writing study protocols, investigator brochures, study summaries, clinical study reports, or other clinical documents. The Technical Writing Specialist may participate in the scientific aspects of clinical studies throughout the duration of the study including providing guidance to address questions regarding scientific and related procedural issues from investigators. He / she will support clinical teams as the medical writing representative, bearing the responsibility for timely and accurate completion of medical writing deliverables.
This position requires the ability to perform activities consistent with general office/ administrative work.
This position is based in a general office/administrative environment. It also involves travel to off-site locations including clinician’s offices, health care settings, and occasional visits to intensive care units and/or operating suites.