CSR Appendices Oversight Manager

Novartis Farmacéutica; London; Hybrid; GBP 100,000 - 125,000; Full time

Job summary

A leading pharmaceutical company is seeking a professional for a hybrid role in London to oversee CSR appendices and manage submission readiness. The ideal candidate will have a Bachelor’s degree in life sciences and experience in clinical development. Responsibilities include overseeing document management processes and collaborating with stakeholders to ensure timely submissions to health authorities. The company promotes an inclusive and diverse work environment.

Qualifications

• 3-5 years in clinical development/operations or similar; 2-3 years experience with document management systems.
• Thorough knowledge of clinical document management processes and documentation guidelines.
• Strong understanding of technical processes, and ability to work independently.

Responsibilities

• Manage, coordinate, and oversee CSR appendices for assigned studies.
• Support implementation of submission document readiness management strategies.
• Develop and maintain submission readiness processes.

Skills

Clinical document management

Project management

Communication skills

Organizational skills

Education

Bachelor's degree in life sciences, healthcare, pharmacy, or information management

Tools

Microsoft Office Suite

Job description

Responsible for the delivery and oversight of CSR appendices authoring, formatting, compilation, and publishing required for regulatory submissions, ensuring rapid, accurate, and timely submissions to health authorities.

Drives implementation of CDGM initiatives, projects, and process improvement activities to enhance clinical document management systems, processes, and standards at Novartis.

This is a hybrid position based in either London or Dublin offices.

About the Role

Major accountabilities:

1. Manage, coordinate, and oversee CSR appendices for assigned studies to meet electronic publishing requirements, Health Authority guidelines, Good Clinical Practices, and Novartis SOPs.
2. Support the implementation of submission document readiness management strategies for clinical documents and templates.
3. Execute vendor oversight plans, monitor service metrics, and identify opportunities for improvement. Act as a point of escalation for issues.
4. Develop and maintain submission readiness processes; contribute to or lead initiatives to improve business and technical aspects of submission readiness activities in collaboration with other CDGM groups, business units, and IT functions.
5. Collaborate with cross-functional stakeholders (e.g., Regulatory Writing & Submissions, Regulatory Affairs, Trial Management) on planning, preparation, and delivery of high-quality documents within timelines, including urgent requests to meet regulatory deadlines.
6. Identify and communicate processing risks, trends, and patterns related to CSR appendices; work with stakeholders to define and implement remediations.
7. Serve as Subject Matter Expert on CSR appendices training materials, processes, and tracking tools in collaboration with the CDM Process team and other stakeholders.
8. Provide audit/inspection support, contribute to root cause analysis, and assist in the creation and delivery of CAPAs.
9. Qualifications include a Bachelor's degree in life sciences, healthcare, pharmacy, or information management, with relevant industry experience.
10. Thorough knowledge of clinical document management processes and advanced knowledge of clinical documentation guidelines (Good Documentation Practice, Data Integrity, ICH eCTD, FDA PDF formatting).
11. Experience in authoring, compiling, and formatting CSR appendices according to ICH E3 standards.
12. 3-5 years in clinical development/operations or similar; 2-3 years experience with document management systems.
13. Strong understanding of technical processes, PC environment, and Microsoft Office Suite.
14. Ability to work independently and experience with project management in a global, multicultural environment.
15. Excellent communication, organizational, and tracking skills.

Novartis is committed to building an inclusive, diverse work environment reflecting the patients and communities we serve.

Why Novartis: Helping people with disease and their families requires more than science. It requires a community of passionate people working together to achieve breakthroughs. Learn more.

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GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.