About the role
TL;DR
Write and edit regulatory documents, coordinate reviews, and manage writing project timelines.
- •Provide medical writing services and consultation to clinical research scientists, academic partners, sponsors, and the corporation.
- •This involves researching, writing, reviewing, and editing scientific information, coordinating document reviews, conducting reference searches, and translating research data into regulatory documents and presentations.
- •Key Responsibilities Lead content planning and production of regulatory documents (protocols, investigator brochures, clinical study reports, informed consent forms).
- •Coordinate with authors and technical specialists to translate, write, edit, and proof data for publication.
- •Act as project manager for writing deliverables, tracking timelines and providing progress reports.
- •Participate in quality control reviews for documents written by others.
- •Requirements Bachelor's degree (advanced degrees preferred) and 3-5 years of medical writing experience.
- •Previous experience leading the development of protocols, ICFs, and CSRs.
- •Trained in GCP, GDPR, and HIPAA.
- •Advanced knowledge of EndNote/reference software.
- •Familiarity with graphical software and figure development is an asset.
Required skills
Google CloudGDPRHIPAA
Domain expertise
healthcare
Tech stack
Google CloudGDPRHIPAA