CSR Appendices Oversight Manager

Novartis Farmacéutica; London; Hybrid; GBP 40,000 - 80,000; Full time

Job summary

An established industry player is seeking a dedicated professional to oversee clinical document management and regulatory submissions. This hybrid role offers the opportunity to work in a dynamic environment, ensuring compliance with health authority guidelines and enhancing clinical processes. You will collaborate with cross-functional teams, driving improvements and innovations in submission readiness. If you are passionate about making a difference in the healthcare sector and thrive in a collaborative atmosphere, this role could be your next career milestone. Join a community committed to transforming patient lives through innovative science and teamwork.

Qualifications

• 3-5 years in clinical development or similar business area.
• Thorough knowledge of clinical document management processes.

Responsibilities

• Manage and oversee CSR appendices for regulatory submissions.
• Collaborate with stakeholders to ensure high-quality document delivery.

Skills

Clinical Document Management

Regulatory Submissions

Project Management

Communication Skills

Document Management Systems

Good Documentation Practice

Data Integrity

Microsoft Office Suite

Education

Bachelor’s degree in life-sciences/healthcare/pharmacy/information management

Tools

Document Management Systems

Microsoft Office Suite

Job description

Responsible for delivery and oversight of CSR appendices authoring, formatting, compilation and publishing required for regulatory submissions, and achieve 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:

• Responsible for efficient and appropriate management, coordination and oversight of CSR appendices for assigned studies to meet electronic publishing requirements, Health Authority guidelines, Good Clinical Practices and Novartis SOPs.
• Support implementation of the submission document readiness management strategy for clinical documents and clinical document templates.
• Executes vendor oversight plan, monitors service metrics and identifies opportunities for improvement to the operating model. Acts as point of escalation for issues.
• Develop and maintain submission readiness processes, contribute to or drive initiatives to improve and innovate business and technical aspects of submission readiness activities, in collaboration with other CDGM groups, business and IT Functions.
• Collaborate with cross-functional stakeholders (e.g., Regulatory Writing & Submissions, Regulatory Affairs, Trial Management, etc.) on the planning, preparation, and delivery of high-quality documents within timelines, including expedited support for urgent requests to meet regulatory deadlines.
• Identify and communicate processing risks/trends/patterns related to CSR appendices and work with key stakeholders to define and implement appropriate remediations.
• Serves as Subject Matter Expert on CSR appendices training materials, formal and informal processes, and tracking tools for CSR appendices oversight activities in collaboration with CDM Process team and other key stakeholders.
• Provides Audit/Inspection support, contributes to root cause analysis identification and creation/delivery of CAPAs.

Qualifications:

• Bachelor’s degree in life-sciences/healthcare/pharmacy/information management and relevant industry experience.
• Thorough knowledge of clinical document management processes.
• Advanced knowledge of clinical documentation practice guidelines & principles (Good Documentation Practice, Data integrity, ICH eCTD and FDA Portable Document formatting specifications (PDF) guidance).
• Experience of authoring, compilation and formatting of CSR appendices according to ICH E3.
• 3-5 years in clinical development/clinical operations or similar business area.
• 2-3 years working experience with document management systems and excellent understanding of system structures and generic document management functionality.
• Good understanding of technical processes and PC environment including Microsoft suite of products.
• Advanced ability to work independently.
• Experience with project work or project management in a global, cross-functional multicultural and international matrix organization.
• Excellent communication, organization and tracking skills.

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Why Novartis: 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? Learn more.

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: Join our network.

GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.

Alternative Location 1 Dublin (NOCC), Ireland

Functional Area Research & Development

Job Type Full time

Employment Type Regular

Shift Work No