Medical Writer
Core
Provide medical writing services and consultation to Clinical Research Scientists, Academic partners, Sponsors, and the Corporation by researching, writing, reviewing, and editing scientific information for regulatory documents and presentations.
Role type
Medical Writer (Clinical Research/Academic)
Builds
Regulatory documents (protocols, investigator brochures, clinical study reports, informed consent forms) and training materials
Domain
Clinical Research / Medical Writing
Deliverable
client delivery
Required skills
Medical writing, regulatory document development, project management, quality control review, reference searching, citation verification, GCP training, GDPR compliance, HIPAA compliance, EndNote proficiency
Preferred skills
Advanced degrees, graphical software familiarity, figure development, Gastroenterology knowledge, ICH M11 familiarity, AMA Style Guide familiarity
Technologies
EndNote
Responsibilities
Lead content planning and production of regulatory documents; Coordinate with authors/technical specialists to translate, write, edit, and proof data and content; Act as project manager for writing deliverables and track timelines; Participate in quality control review for documents written by other authors; Act as liaison with external publication executives, illustrators, designers, and editors; Support study teams with review, editing, or proof-reading of study documents or templates; Assist with writing or reviewing relevant training materials or work instructions
