Senior Regulatory Medical Writer, Client-embedded, FSP
Core
Senior Medical Writer providing high-quality medical and scientific writing for clinical and preclinical regulatory documents to internal and external clients.
Role type
Senior IC regulatory medical writer
Builds
Clinical study reports, protocols, IBs, bioassay reports, INDs, and MAAs
Domain
Pharmaceutical/CRO industry, clinical research
Required skills
clinical regulatory document authoring, data interpretation, project management, document management systems, global/regional/national guideline knowledge
Preferred skills
preclinical regulatory document authoring, pharmaceutical/CRO industry experience, AMWA/EMWA/RAC certifications
Technologies
document management systems, Excel, Outlook
Responsibilities
Author routine clinical documents (CSRs, protocols), author complex clinical/scientific documents (IBs, INDs, MAAs), collaborate with cross-functional teams, ensure regulatory alignment, review team member documents, manage project timelines, mentor junior writers
Seniority
Senior, hands-on IC
