Salary Range: €46,300.00 - €86,100.00 Band Level 4 Job Description Summary Job Title: Submission Readiness Document Manager #LI-Hybrid Primary Location: Barcelona, Spain Relocation Support: This role is based in Barcelona Gran Via, Spain. Novartis is unable to offer relocation support: please only apply if accessible.
Ready to play a critical role in delivering life-changing medicines to patients worldwide? As a Submission Readiness Document Manager, you will ensure that clinical documents are technically compliant, and submission-ready - enabling timely and accurate regulatory submissions. You'll collaborate across integral teams, drive process improvements to enhance clinical document management systems, processes and standards at Novartis. This role offers a unique opportunity to shape how clinical documents support regulatory success while strengthening operational excellence across a fast-paced, global environment.
Job Description Key Responsibilities

Manage 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 initiatives
Act as escalation point for submission readiness issues and resolve operational challenges
Identify risks, trends, and gaps in submission processes and implement appropriate 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
Essential Requirements

Bachelor's degr

📌 Submission Readiness Document Manager (Madrid)
🏢 ES06 (FCRS = ES006) Novartis Farmacéutica
📍 Madrid