At a Glance
- Tasks: Manage clinical documents to ensure they are submission-ready and compliant with regulations.
- Company: Join Novartis, a leader in delivering life-changing medicines globally.
- Benefits: Competitive salary, flexible working options, and comprehensive benefits package.
- Other info: Dynamic role with opportunities for professional growth in a collaborative environment.
- Why this job: Make a real impact on patient lives by ensuring regulatory success.
- Qualifications: Bachelor's degree in life sciences and 3-5 years of relevant experience.
The predicted salary is between 49140 - 91260 £ per year.
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, global environment.
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 Requirements
- Bachelor’s degree in life sciences, healthcare, pharmacy, or information management
- Proven experience in clinical development, clinical operations, or a similar environment (3–5 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, we’re committed to reimagining medicine together - and rewarding the people who make it happen.
Expected Annual Base Salary Range for role: 49,140 to 91,260 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 programs. In 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.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
Submission Readiness Document Manager employer: Novartis Farmacéutica
At Novartis, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation in the healthcare sector. Our commitment to employee growth is evident through continuous training and development opportunities, ensuring that our team members can thrive while making a meaningful impact on patient access to life-changing medicines in Southwest England and South London.
StudySmarter Expert Advice🤫
We think this is how you could land Submission Readiness Document Manager
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We think you need these skills to ace Submission Readiness Document Manager
Some tips for your application 🫡
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Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Novartis Farmacéutica that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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