• 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.