Senior Medical Writer

Main Responsibilities & Technical Competencies

• 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
• Avoid proper planning and resourcing of all documents assigned to Writing/Editing Team
• Able to work across multiple projects and accounts simultaneously
• 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
• Demonstrate a good understanding of project management and resource planning
• 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
• Communication: Understand the purpose and role of communications in the wider therapy area and commercial landscape
• Communicate clearly to different audiences through a variety of media (print and digital)
• Identify and communicate important therapy area updates and any medical/regulatory milestones to the team and clients where appropriate. Link this with any potential new business opportunities where applicable
• Provide regular feedback to senior teams across accounts and projects
• Mentor less experienced medical writers

EHS responsibilities

• Comply with applicable EHS regulations and procedures
• Participate in the site's EHS performance by reporting risks, malfunctions or improvements
• Participate in mandatory EHS training

Knowledge & Experience

• 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 is required; working knowledge of other ex-US regulatory requirements is desired
• 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 reprioritise 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