Senior Medical Writer
4 days ago
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 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 within Medical Writing and beyond Ensure compliance with internal SOPs and global regulatory standards What you'll need to succeed Bachelor's degree or higher in a scientific disciplineFormal training or certification in medical writing (e.g., AMWA, DIA) is highly desirable. Expert medical writing experience in pharma/biotech circa 6 years Strong track record of authoring documents across all phases of clinical developmentExperience 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 return Work 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