Position Overview
Your new company
We are seeking an experienced Medical Writer with strong regulatory expertise to support a rapidly growing Regulatory Affairs consultancy. They count some of the biggest multinational pharmaceutical companies as clients and continue to provide regulatory solutions that drive success.This is a fully remote, UK-based contract opportunity (outside IR35), ideal for a consultant with a proven track record in regulatory submission documents.
Your new role
Author, review, and edit regulatory documents in line with global submission requirements.
Update existing documents: Clinical Overview (Module 2.5) and Clinical Summary (Module 2.7) documents.
Collaborate cross-functionally with clinical, regulatory, and biostatistics teams.
Ensure consistency, scientific accuracy, and compliance with ICH guidelines.
Manage document timelines and incorporate feedback from multiple stakeholders.
Support preparation for regulatory submissions...