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Job Post Details

Senior Regulatory Medical Writer - job post

Clearline Recruitment
Welwyn•Hybrid work
£45.50 - £75.00 an hour - Full-time, Fixed term contract

Job details

Pay

  • £45.50 - £75.00 an hour

Job type

  • Fixed term contract
  • Full-time

Location

Welwyn•Hybrid work

Benefits

Pulled from the full job description

  • Annual leave
  • Free parking
  • Additional leave
  • Work from home
  • On-site parking

Full job description

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 01273 063769 between 8:30am – 5:00pm.

Pay: £45.50-£75.00 per hour

Benefits:

  • Additional leave
  • Free parking
  • On-site parking
  • Work from home

Work Location: Hybrid remote in Welwyn

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