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:

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

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

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