Submission Readiness Document Manager (3 Available)

Job Description

100,000 and more! That’s how many patients are treated in our studies. And every year, 3 million documents are uploaded in the electronic Trial Master Files to preserve the story of the study and ensure innovative medicines can reach even more patients worldwide.
But in this world of digital and technological transformation, we must also continue to evolve our approaches to clinical document management and unleash the power of information from this expanding universe of data.

The Submission Readiness Document Manager will be responsible for submission readiness of clinical documents: authoring, formatting, and publishing clinical documents required for regulatory submissions to support 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.

Main accountabilities:

• Responsible for efficient and appropriate management of submission-relevant documentation ((e.g., Protocol, CSR, ICF, PDR, etc.) for global clinical,) 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.
• 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.
• Identifies and communicate processing risks/trends/patterns related to regulatory submission documents and works with key stakeholders to define and implement appropriate remediations.
• Serves as Subject Matter Expert on Regulatory Document Manager training materials, formal and informal processes and tracking tools for submission readiness 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.

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

This position can be located in India, UK, Ireland, or US (East Hanover, NJ). Should you be interested in a non-US listed location, please refer to requisition 364029BR to apply. Please note relocation will not be provided.

What you'll bring to the role:
• 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 best practice guidelines & principles (good documentation practice, data integrity)
• 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

#GCO
#CDGM

Why consider Novartis?
736 million. That’s how many lives our products touched in 2022. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

The pay range for this position at commencement of employment is expected to be between $124,000 and $186,000/year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis
Network here: https://talentnetwork.novartis.com/network