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 Requir

📌 Submission Readiness Document Manager (Barcelona)
🏢 Novartis
📍 Barcelona