Senior Principal Regulatory Submissions Medical Writer

The role

Regulatory filings stall when the integrated summaries and clinical overview aren't written well, and this remote seat exists to write them. You'll develop submission documents to ICH and other global guidelines under a client's authoring standards, build timelines with the study teams, and manage internal and contract writers. Experience with ISE, ISS and clinical overview documents is flagged as a must-have, alongside five years of medical writing in biopharma or a CRO. Open to candidates in the US or Canada.

Tools and skills