At a Glance
- Tasks: Manage clinical documents to ensure they are submission-ready and compliant with regulations.
- Company: Join Novartis, a leader in life-changing medicines with a commitment to innovation.
- Benefits: Competitive salary, performance bonuses, flexible working, and comprehensive benefits package.
- Other info: Dynamic, inclusive environment with opportunities for professional growth.
- Why this job: Play a vital role in delivering medicines that impact lives globally.
- Qualifications: Bachelor's degree in life sciences and 3-5 years in clinical development or operations.
The predicted salary is between 14000 - 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
Skills Desired
- Budget Management
- Clinical Trials
- Process Improvements
- Project Planning
- Vendor Management
- Waterfall Model
Submission Readiness Document Manager in London employer: Novartis
At Novartis, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. Our hybrid work model allows for flexibility while providing ample opportunities for professional growth and development in the pharmaceutical industry. With a commitment to enhancing customer experiences for healthcare professionals and patients alike, joining our team means contributing to meaningful work that makes a difference in people's lives.
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We think this is how you could land Submission Readiness Document Manager in London
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We think you need these skills to ace Submission Readiness Document Manager in London
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Novartis!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Novartis that you're not just a fit for the job but also a safety-conscious candidate!
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How to prepare for a job interview at Novartis
✨Understand the Science
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 that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
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In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
