Senior Regulatory Medical Writer

Role: Senior Regulatory Medical Writer

Location: Hybrid - Welwyn

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.

This senior-level role will focus on developing regulatory content strategies and delivering high-quality clinical, safety and medical device documentation for global submissions. The successful candidate will work independently, lead cross-functional contributors and help shape submission content throughout the product lifecycle.

Benefits:

• 25 days holiday + bank holidays
• 12-month contract outside IR35
• Hybrid working based in Welwyn
• Free, on-site parking
• Opportunity to support global regulatory submissions
• Exposure to pharmaceutical and medical device programmes
• Senior-level strategic and cross-functional responsibility

The Requirements:

• Degree in Life Sciences or an equivalent scientific discipline
• At least 5 years of relevant experience within the pharmaceutical or biotechnology industry
• Strong medical and regulatory writing experience
• Experience independently managing complex regulatory writing projects
• Experience producing clinical protocols and pharmacovigilance documents, including DSURs and PBRERs
• Strong understanding of clinical, safety and medical device regulatory documentation
• Familiarity with drug and device development regulations, including GCP, GVP, ICH, ISO and MDR/IVDR
• Experience supporting global filings and regulatory submissions strongly preferred
• Proven ability to lead cross-functional teams and manage stakeholder input
• Excellent scientific writing, editing and project-planning skills
• Experience with Veeva Vault, Adobe Acrobat, Microsoft Office and Google Workspace desirable

The Role:

• Lead the development and delivery of regulatory content strategies
• Prepare and oversee clinical, safety and medical device documentation
• Produce protocols, DSURs, PBRERs and other regulatory submission documents
• Plan document timelines and manage content from initiation through approval
• Review documentation for scientific quality, clarity, consistency and compliance
• Lead cross-functional contributors and resolve content-related issues
• Support global regulatory filings and submission planning
• Contribute to content standards, strategic reuse and process improvement initiatives
• Maintain awareness of relevant regulatory, scientific and medical developments
• Mentor less experienced writers or Content Strategists where required

If you're keen to join an exceptional team who can offer strategic regulatory exposure, global submission work and senior-level ownership across clinical, safety and device content, then please apply to this Senior Regulatory Medical Writer role below or call Chloe McCausland on between 8:30am - 5:00pm.