Principal Clinical Medical Writer
| Posting date: | 16 September 2025 |
|---|---|
| Salary: | £70,000.0 to £90,000.0 per year |
| Additional salary information: | + benefits |
| Hours: | Full time |
| Closing date: | 23 September 2025 |
| Location: | City of London, London, EC2V 6DB |
| Remote working: | Hybrid - work remotely up to 3 days per week |
| Company: | Hays Specialist Recruitment |
| Job type: | Permanent |
| Job reference: | 4725034_1758045852 |
Summary
Your new company
Are you a senior-level medical writing professional ready to take the lead on global clinical documentation strategy? We're working with a top-tier international biopharmaceutical company-a trailblazer in rare disease innovation-to recruit a Principal Clinical Medical Writer to join their Clinical Development function.This is a high-impact role offering strategic oversight, cross-functional leadership, and the opportunity to shape regulatory documentation across multiple programs and therapeutic areas.
Your new role
As Principal Clinical Medical Writer, you'll be responsible for leading the medical writing effort across clinical development programs, managing timelines, mentoring writers, and ensuring the delivery of high-quality, compliant documentation for global regulatory submissions.You'll work closely with the Head of Medical Writing and cross-functional teams to drive consistency, efficiency, and excellence in clinical content.
Key Responsibilities
- Provide functional oversight and mentorship to medical writing staff
- Lead the development of clinical and regulatory documents including protocols, CSRs, IBs, PBRERs, DSURs, and briefing books
- Manage timelines, resources, and review cycles across multiple programs
- Represent Medical Writing in cross-functional meetings and strategic planning sessions
- Support regulatory submissions (INDs, NDAs, BLAs) including eCTD Modules 2 & 5, ISS/ISE
- Contribute to process improvement and template development across departments
- Ensure compliance with global regulatory standards and internal SOPs
What you'll need to succeed
- Master's degree or higher in a scientific discipline preferred
- Formal training or certification in medical writing (e.g., AMWA, EMWA, DIA) is highly desirable.
- Expert experience of medical writing in pharma/biotech
- Proven leadership in managing writing teams or projects
- Strong track record of authoring documents across all phases of drug development
- Experience with INDs, NDAs/BLAs, periodic safety documents, and regulatory briefing books
- Familiarity with eCTD structure and integrated summaries (ISS/ISE)
- Advanced understanding of clinical research, biostatistics, and regulatory frameworks
- Proficiency in Microsoft Office Suite, Adobe Acrobat, MS Project, and document management systems (e.g., Veeva, SharePoint)
- Excellent project management and stakeholder engagement skills
- Clear, concise communication with the ability to translate complex science into regulatory-ready documentation
What you'll get in return
- Join a globally recognised biotech innovator with a strong pipeline
- Lead strategic initiatives and mentor a high-performing team
- Hybrid working model with flexibility and autonomy
- Competitive package with long-term career growth
What you need to do now
Before you apply for this position, it is vital that you are in possession of a UK passport or relevant visa to work without restrictions in the UK and residing in the UK.
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins on 03330106292