Senior Technical Document Editor

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Summary

Grifols Diagnostic Solutions is seeking a Senior Technical Document Editor to help support our Labeling department in San Diego, CA. This position will provide formatting and maintenance of technical documentation in support of instrument and software operator manuals, package inserts, SOPs, specifications and training materials.

Primary Responsibilities for Role

• Provide strategic direction and mentorship to other technical editors in the team, fostering a culture of excellence, collaboration and continuous improvement 
• Lead the entire process of acquiring translated package inserts and operator manuals by communicating objectives and timelines with external vendors for translation projects, reviewing and approving translated documents upon receipt, acquisition of the Certificate of Translation for compliance, and submission of all relevant documentation to be made effective in the eDMS upon completion of the translation project  
• Lead reviews and presentations to project teams, internal and external stakeholders, and regulatory authorities as required     
• Manages labeling change requests, creates and implements templates, style guides, and documentation standards to ensure consistency and quality across all technical documentation, submits finalized documentation for review and approval from internal departments 
• Execute on project management tracking and priorities by keeping internal trackers and databases up to date, partnering with stakeholders to provide and maintain accurate data, ensuring deadlines and deliverables are met on time        
• Edit and maintain technical documentation including operator manuals, package inserts, and regulatory submission documents in compliance with regulatory requirements and company standards      
• Edit documents to support Labeling Development in compliance with ISO, cGMP, EU MDR and FDA guidelines, working within established formats and templates  
• Identify and inform areas for improvement to Labeling processes, styles, formats, and participate/support in execution of continuous improvement initiatives as appropriate
• Represent Labeling Development on Core Teams and collaborate closely with cross-functional teams including Regulatory Affairs, Marketing, Research & Development Instruments, Product Support and Quality Assurance to understand project requirements and ensure alignment on editing timelines          
• Revise documentation as requested by stakeholders                    
• Manage documentation, including version control, review and approvals process, generating clean and redlined drafts in accordance with established procedures               
• Manage the creation, review, approval, distribution, and archival of all controlled documents within Labeling Development, including label and packaging artwork and drawings, package inserts, operator's manuals, work instructions, SOPs, forms, and quality records                    
• Maintain document repositories and electronic document management systems (eDMS), ensuring accurate document metadata, version control, and document history      
• Collaborate in-person with cross-functional departments to mitigate operational constraints (batch record discrepancies, GDP errors etc.)                    
• Assist in-person demonstrations related to content of technical documents, especially for instrument and software documentation                    

Additional Responsibilities

• Organize and maintain department files, databases and spreadsheets
• Support and execute on Change Control processes in a timely manner
• Develop comprehensive project plans, outlining key milestones, deliverables and resource requirements
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