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 .