Submission Readiness Document Manager
Primary

Location:
Barcelona, Spain — Hybrid. Relocation support is not offered;

please apply onlyif you can work in Barcelona.
Salary Range: €46,300.00 – €86,100.00Key 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 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 expertise in clinical document management processes and regulatory requirements.
Advanced knowledge of documentation best practices, including data integrity and good documentation principles.
Experience working with document management systems and a strong understanding of system structures and functionality.
Ability to manage projects in a global, cross‑functional environment.
Strong organizational, tracking, and communication skills.
High level of independence with the ability to manage complex priorities effectively.
Desired Skills
Budget ManagementClinical TrialsProcess ImprovementsProject PlanningVendor ManagementWaterfall ModelBenefits & Rewards
In addition to the base salary, you may be eligible for a performance‑based bonus. You will receive a competitive benefits package that includes insurance plans, retirement plans, wellbeing resources, and global recognition programs. Flexible and hybrid working options are offered where possible, and a minimum of 14 weeks paid parental leave is available. Pay equity is a fundamental part of our employment policy, reflecting our commitment to create a diverse, equitable and inclusive environment. Learn more about our general total rewards offering: to Diversity and Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. We are devoted to creating a diverse, equitable and inclusive workplace that respects all employees.

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