Submission Readiness Document Manager
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Job Summary
Salary Range:
49140.00 - 91260.00Job Description Summary
Job Title: Submission Readiness Document Manager#LI-Hybrid
Primary Location: London United Kingdom
Relocation Support: This role is based in London United Kingdom. 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-readyenabling timely and accurate regulatory submissions. Youll 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 global environment.
Job Description
- Manage submission-readiness of clinical documents ensuring compliance with regulatory requirements and quality standards
- Overseetechnical editorialandformatting 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
- Bachelors degree in life sciences healthcare pharmacy or information management
- Proven experience in clinical development clinical operations or a similar environment (35 years)
- 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 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
Benefits & Rewards
At Novartis were committed to reimagining medicine together - and rewarding the people who make it happen.
Expected Annual Base Salary Range for role:49140 to 91260 GBP
The base salary offered is determined based on gender-neutral objectives such as relevant skills competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.
In addition to your base salary you may be eligible for a performance-based bonus depending on certain performance parameters.
The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally such as insurance plans retirement plans wellbeing resources and global recognition addition we provide flexible and hybrid working options where possible and minimum 14 weeks paid parental leave.
Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse equitable and inclusive environment that treats all employees with dignity and respect as outlined in our Code of Ethics.
Read our brochure to learn more about our global total rewards offering:
Commitment to Diversity and Inclusion / EEO paragraph
Novartis is committed to building an outstanding inclusive work environment and diverseteamsrepresentative of the patients and communities we serve.
Skills Desired
Budget Management Clinical Trials Process Improvements Project Planning Vendor Management Waterfall ModelRequired Experience:
Manager
About Company
Novartis is a global healthcare company based in Switzerland that provides solutions to the evolving needs of patients worldwide.
