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.
