Manage the preparation of a complex suite of regulatory documents e.g. protocols, CSRs, briefing documents, meeting requests, investigator brochures, clinical modules.
Lead Writing/Editing complex Clinical Dossiers/Safety Reports.
Review documents to ensure compliance with documentation quality standards, regulatory requirements and consistency of messages across all documents for a product within a clinical dossier.
Plan and create timelines to produce assigned documents.
Ensure proper planning and resourcing of all documents assigned to Writing/Editing Team.
Actively contribute to best practices and continuous improvement within the therapeutic Area.
Represent the group in functional and cross functional initiatives/projects when required.
Network and share best practices to ensure efficiency and consistency across product teams.
Demonstrate a thorough understanding of timelines, budgetary constraints and scopes of work.
Adhere to the quality control process and ensure all work produced has gone through the correct internal review process.
Maintain a working knowledge of pharmaceutical industry standards and compliance.
Stay informed of upcoming projects, assist management in projecting resources, and perform administrative duties as requested.
Identify and participate in the qualification of Medical Writing consultants and vendors, and oversee their writing activities to ensure timely and quality deliverables are completed within budget.

5+ years of experience in clinical and regulatory medical writing within pharmaceutical, biotechnology, academic, or CRO settings.
Working knowledge of ICH and US regulatory requirements.
Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.
Proficient in using Microsoft Office programmes (e.g. PowerPoint, Excel, etc.).
A keen interest in working and developing scientific expertise across a range of therapy areas.
Flexible approach to working, with the ability to reprioritize and work under pressure when needed.
Excellent time management skills and demonstrated ability to forecast and manage workload.
Experience as a clinical/regulatory/safety Medical Writer, i.e., preparation of a wide range of clinical/regulatory documents including Clinical Study Reports, Protocols, Subject Narratives, Investigator Brochures, Regulatory Submission Modules, Safety Reports, and Manuscripts.
Able to manage coordination responsibilities beyond writing individual documents, e.g., timelines, reviews and submissions.

Medical Writer, Project Lead

Key skills