Your newpany

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 pharmaceuticalpanies 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.Lead the development of Clinical Overview (Module and Clinical Summary (Module documents.Collaborate cross-functionally with clinical, regulatory, and biostatistics teams.Ensure consistency, scientific accuracy, andpliance with ICH guidelines.Manage document timelines and incorporate feedback from multiple stakeholders.Support preparation for regulatory submissions ( CTD/eCTD).

What you'll need to succeed