The Senior Scientific Writer is the medical writing expert responsible for the research, writing and editing of regulatory documents. The incumbent will provide full lifecycle support from clinical study protocols through regulatory dossier preparation and submission. Responsibilities will include participating in the development of the strategy of the submission and the label and the carrying through of those key messages into other regulatory documents, assuring quality and timely preparation of clinical documents across all therapeutic areas, including clinical study reports, clinical study protocols, investigator’s brochures, and clinical summaries and overviews.
A Bachelor’s degree or equivalent, with a minimum of six years in Medical Writing or a Master’s degree, PhD, or equivalent with a minimum of five years previous industry experience and three years of medical writing experience is required. The candidate must have a demonstrated working knowledge of scientific principles and excellent written and oral communication skills in English. Also required is familiarity with all phases of medical research and ability to learn new medical concepts quickly, familiarity with statistics and experimental design and the ability to summarize complex data and identify relationships.