Job Description
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 Responsibilities
Author 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 deliverables
Contribute to the development of templates and best practices withi...