Senior Medical Writer - City of London
Your new company
Are you a seasoned medical writer with a sharp eye for detail and a deep understanding of clinical development? We're working with a leading international biopharmaceutical company-a pioneer in rare disease innovation-to recruit a Senior Medical Writer to join their high-performing Global Medical Writing team.This is a unique opportunity to contribute to cutting-edge therapies while shaping regulatory and clinical documentation across all phases of drug development.
Your new role
As a Senior Medical Writer, you'll be responsible for authoring and managing a wide range of regulatory and clinical documents, from protocols and study reports to briefing books and eCTD modules. You'll collaborate with cross-functional teams, lead document strategy, and ensure content meets global regulatory standards.
Key ResponsibilitiesAuthor and edit clinical study documentation: protocols, amendments, ICFs, CSRs
Prepare regulatory documents including Investigator's Brochures, PBRERs, DSURs, INDs, and NDA/BLA components.
Lead document planning, timelines, and review cycles across study teams
Represent Medical Writing in cross-functional meetings and development teams
Provide peer review and editorial support across regulatory deliverablesContribute to the development of templates and best practices within Medical Writing and beyond
Ensure compliance with internal SOPs and global regulatory standards
What you'll need to succeedBachelor's degree or higher in a scientific discipline
Formal training or certification in medical writing (e.g., AMWA, DIA) is highly desirable.
Expert medical writing experience in pharma/biotech
Strong track record of authoring documents across all phases of clinical development
Experience with INDs, NDAs/BLAs, PBRERs, DSURs, 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, and document management systems (e.g., Veeva, SharePoint)
Strong project leadership and stakeholder management skills
Excellent written and verbal communication with the ability to translate complex science into clear, compliant documentation
What you'll get in returnWork with a globally recognised biotech innovator
Be part of a collaborative, science-driven culture
Hybrid working model with flexibility and autonomy
Competitive package with long-term career development
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