Medical Writer II / Senior Medical Writer
Core
Coordinate, write, and edit clinical study documents including Investigator Brochures, Clinical Study Protocols, Participant Information and Consent Forms, and Clinical Study Reports for pharmaceutical and biotechnology clients.
Role type
Senior Medical Writer (Regulatory)
Builds
Clinical study regulatory documents for drug development projects
Domain
Pharmaceutical / Biotechnology / Clinical Research
Required skills
Clinical study document preparation, ICH GCP guidelines, medical terminology, clinical trials processes, research report writing, statistics and data analysis, pharmacokinetics, mentoring, MS Office suite
Preferred skills
Higher degree in scientific discipline, peer-reviewed journal article publication, advanced pharmacokinetics knowledge
Responsibilities
Coordinate and write Investigator Brochures, Clinical Study Protocols, PICFs, and CSRs; serve as primary technical contact for clinical documents; mentor Medical Writers; maintain quality processes
Seniority
Senior, hands-on IC
