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 global 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, integral environment.Job Description Key ResponsibilitiesManage submission-readiness of clinical documents,



ensuring compliance with regulatory requirements and quality standardsOversee technical editorial and formatting of clinical documents for regulatory submissionsEnsure clinical documentation meets Health Authority guidelines, Good Clinical Practice, and Novartis proceduresSupport implementation of submission readiness strategies and standardized document templatesCollaborate with cross-functional teams to deliver high-quality documents within timelinesMonitor vendor performance, track service metrics, and drive continuous improvement initiativesAct as escalation point for submission readiness issues and resolve operational challengesIdentify risks, trends, and gaps in submission processes and implement appropriate mitigationsServe as Subject Matter Expert for submission readiness processes, tools, and training materialsSupport audits and inspections, including root cause analysis and corrective and preventive actionsEssential RequirementsBachelor's degree in life scien

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