Role: Senior Regulatory Medical Writer
Location: Welwyn (Hybrid)
Hours: Full-time
Pay: £45.50 - £56.40 per hour PAYE basic (excluding holiday pay) or £60 - £75 per hour LTD / UMB
Contract: 12-Month Contract (outside IR35)

An excellent opportunity has arisen for a Senior Regulatory Medical Writer to join one of our longstanding global pharmaceutical clients on a 12-month contract basis outside IR35.

In this role, you will contribute to the preparation and delivery of high-quality regulatory and clinical documentation to support product development and global regulatory submissions.

Benefits:
*12-month contract outside IR35
*Hybrid working in Welwyn
*Opportunity to work on innovative pharmaceutical and device programmes
*Collaborative global regulatory environment

The Requirements:
*Degree in Life Sciences or a related discipline
*Significant experience in regulatory or clinical medical writing within the pharmaceutical or biotechnology industry
*Strong experience preparing clinical protocols and pharmacovigilance documentation
*Experience writing DSURs and PBRERs
*Understanding of global regulatory guidelines and submission requirements
*Experience working on combination products or medical devices - desirable
*Excellent written communication and document management skills

The Role:
*Prepare and review regulatory and clinical documentation including clinical study protocols
*Author and maintain pharmacovigilance documents such as DSURs and PBRERs
*Interpret scientific and clinical data to produce clear and compliant regulatory content
*Collaborate with cross-functional teams including clinical, safety and regulatory colleagues
*Ensure documentation aligns with global regulatory standards and internal processes
*Support submission timelines and contribute to regulatory strategy discussions

If you’re keen to join an exceptional team working on innovative pharmaceutical programmes, then please apply to this Senior Regulatory Medical Writer role below or call Chloe McCausland on between 8:30am - 5:00pm.