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- Tasks: Manage and oversee CSR appendices for regulatory submissions, ensuring timely and accurate delivery.
- Company: Join Novartis, a leader in healthcare committed to inclusivity and innovation.
- Benefits: Enjoy a hybrid work model, competitive rewards, and a supportive community.
- Why this job: Be part of a team that drives impactful change in patient lives through collaboration and innovation.
- Qualifications: Bachelor's degree in life sciences and relevant experience in clinical document management required.
- Other info: Fluency in English and advanced knowledge of clinical documentation practices are essential.
The predicted salary is between 43200 - 72000 £ per year.
Job Description
This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
Summary 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 documents 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 works 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.
Minimum Requirements:
- Bachelor's degree in life-sciences/healthcare/pharmacy/information management and relevant industry experience.
- English fluency (written, oral) required.
- 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? https://www.novartis.com/about/strategy/people-and-culture
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: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
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CSR Appendices Oversight Manager employer: Novartis
Contact Detail:
Novartis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land CSR Appendices Oversight Manager
✨Tip Number 1
Familiarize yourself with the specific regulatory guidelines and standards mentioned in the job description, such as ICH E33 and Good Documentation Practice. This knowledge will not only help you understand the role better but also demonstrate your commitment to compliance during the interview.
✨Tip Number 2
Network with professionals in the clinical document management field, especially those who have experience with Novartis or similar organizations. Engaging with them can provide insights into the company culture and expectations, which can be invaluable during your application process.
✨Tip Number 3
Prepare to discuss your experience with document management systems and how you've utilized them in past roles. Be ready to share specific examples of how you've improved processes or managed projects effectively, as this aligns closely with the responsibilities outlined in the job description.
✨Tip Number 4
Highlight your ability to work in a cross-functional team environment. Be prepared to discuss instances where you've collaborated with various stakeholders, as this is a key aspect of the role and will show that you can thrive in a multicultural and international setting.
We think you need these skills to ace CSR Appendices Oversight Manager
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the CSR Appendices Oversight Manager position at Novartis. Understand the key responsibilities and required qualifications, as this will help you tailor your application effectively.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in clinical document management processes and any relevant project management experience. Be specific about your familiarity with ICH guidelines and document formatting standards.
Showcase Communication Skills: Since the role requires excellent communication and collaboration skills, provide examples in your application that demonstrate your ability to work with cross-functional teams and manage stakeholder expectations.
Tailor Your Application: Customize your cover letter to reflect your passion for the role and how your background aligns with Novartis' mission. Mention your commitment to building an inclusive work environment, as this is a core value of the company.
How to prepare for a job interview at Novartis
✨Understand the Regulatory Landscape
Make sure you have a solid grasp of the regulatory requirements related to CSR appendices. Familiarize yourself with ICH guidelines and FDA specifications, as this knowledge will be crucial during your interview.
✨Showcase Your Project Management Skills
Be prepared to discuss your experience in project management, especially in a global and cross-functional context. Highlight specific projects where you successfully coordinated teams and met tight deadlines.
✨Demonstrate Communication Proficiency
Since this role involves collaboration with various stakeholders, emphasize your communication skills. Share examples of how you've effectively communicated complex information to different audiences.
✨Prepare for Technical Questions
Expect questions about document management systems and clinical documentation practices. Brush up on your technical knowledge and be ready to discuss how you've utilized these systems in past roles.
