Submission Readiness Document Manager

About the role

Novartis is looking for a Submission Readiness Document Manager based in Barcelona Gran Via, Spain. The role ensures that clinical documents are technically compliant and submission-ready, enabling timely and accurate regulatory submissions. It involves collaboration across global teams and driving process improvements to strengthen clinical document management systems, processes and standards. Relocation support is not offered.

Key responsibilities

• Manage the submission readiness of clinical documents, ensuring compliance with regulatory requirements and quality standards
• Oversee technical editorial and formatting of clinical documents for regulatory submissions
• Ensure clinical documentation meets Health Authority guidelines, Good Clinical Practice and Novartis procedures
• Support implementation of submission readiness strategies and standardized document templates
• Collaborate with cross-functional teams to deliver high-quality documents within timelines
• Monitor vendor performance, track service metrics and drive continuous improvement
• Act as escalation point for submission readiness issues and resolve operational challenges
• Identify risks, trends and gaps in submission processes and implement mitigations
• Serve as Subject Matter Expert for submission readiness processes, tools and training materials
• Support audits and inspections, including root cause analysis and corrective and preventive actions

Required profile

• Bachelor's degree in life sciences, healthcare, pharmacy or information management
• 3-5 years of proven experience in clinical development, clinical operations or a similar environment
• Strong organizational, tracking and communication skills, with a high level of independence and ability to manage complex priorities

Required skills

• Expertise in clinical document management processes and regulatory requirements
• Knowledge of documentation best practices, including data integrity and good documentation principles
• Experience with document management systems and understanding of their structures and functionality
• Ability to manage projects in a global, cross-functional environment

What we offer

• Base salary range of 46,300 to 86,100 euros, depending on skills, competencies and experience
• Possible performance-based bonus
• Insurance plans, retirement plans, wellbeing resources and global recognition programs
• Flexible and hybrid working options where possible
• Minimum 14 weeks of paid parental leave