Medical Writer (Regulatory)

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 (e.g. CTD/eCTD).

What you'll need to succeed
Several years' experience in medical writing within the pharmaceutical or biotech industry.

Demonstrable expertise in Modules 2.5 and 2.7 (Clinical Overview and Clinical Summary).

Strong knowledge of ICH guidelines and CTD structure.

Proven ability to deliver high-quality documents to tight timelines.

Excellent written and verbal communication skills.

Must be UK-based with right to work.

Experience supporting major regulatory submissions (EMA, MHRA, FDA).

Experience working in a fully remote, cross-functional environment.

What you need to do now
If you are an experienced Medical Writer with strong expertise in Modules 2.5 and 2.7 and are available for your next contract, I'd love to hear from you.

Click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins on (phone number removed)

Before you apply for this position, it is vital that you are in possession of a UK passport or relevant visa to work without restrictions in the UK and must be based in the UK.