Submission Readiness Document Manager

About the role

Join Novartis as a Submission Readiness Document Manager and lead the preparation of clinical documents for regulatory submissions. You will ensure that all documentation complies with Health Authority guidelines, Good Clinical Practice and internal standards while supporting cross‑functional teams to meet tight timelines.

Key responsibilities

• Manage submission‑readiness of clinical documents, guaranteeing regulatory compliance and quality.
• Oversee technical editorial and formatting of documents for regulatory submissions.
• Ensure documentation aligns with Health Authority guidelines, GCP and Novartis procedures.
• Support implementation of submission readiness strategies and standardized templates.
• Collaborate with cross‑functional teams to deliver high‑quality documents on schedule.
• 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.
• Support audits and inspections, including root‑cause analysis and corrective actions.

Required profile

• Bachelor’s degree in life sciences, healthcare, pharmacy or information management.
• 3–5 years of experience in clinical development, clinical operations or a related environment.
• Strong expertise in clinical document management processes and regulatory requirements.
• Advanced knowledge of documentation best practices, data integrity and good documentation principles.
• Ability to manage projects in a global, cross‑functional setting.
• Excellent organizational, tracking and communication skills.
• High level of independence with the ability to manage complex priorities.

Required skills

• Document management systems
• Good Clinical Practice (GCP) knowledge
• Regulatory submission requirements

What we offer

• Competitive annual base salary range: €46,300 – €86,100.
• Performance‑based bonus potential.
• Comprehensive benefits package including insurance, retirement plans and wellbeing resources.
• Flexible hybrid working options.
• Minimum 14 weeks paid parental leave and commitment to pay equity.