Integrated Resources, Inc ( IRI )
New York, NY
Title: Associate Director Medical Writer
Location: REMOTE
Duration: 24+ months (Possibility of extension)
Schedule: Initially, only ~15-25 hours per week are utilized for onboarding and training. If performance is strong, this position could be full time.
Responsibilities The primary responsibilities of an Associate Director Medical Writer include, but are not limited to, leading key medical writing projects and activities across therapeutic areas and preparing (under minimal supervision) scientific and regulatory documents related to the clinical development of investigational and marketed drugs and biologics.
These types of scientific and regulatory documents can include clinical study reports (CSRs), subject narratives, clinical investigator brochures, protocols, briefing documents, and sections of Investigational New Drug Applications (INDs) and New Drug Applications (NDAs)/Biologics License Applications (BLAs) (i.e., integrated summaries of safety and efficacy, product...