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.

Your responsibilities include, but are not limited to:

• Act as CDGM POC for Health Authority Inspection and internal audits - coordinating preparation, support and addressing findings, including identifying root causes of findings, creation of CAPAs and effectiveness checks, monitoring of CAPA execution to ensure deliverables are achieved in line with desired improvement and agreed timeframes.
• Identify and oversee implementation of Health Authority Inspection and internal audits from inspections/audits to improve clinical documentation process, systems and capabilities.
• Partner with network of CDGM Quality responsible persons (QARPs), business and QA stakeholders to ensure Quality Issues and Quality Events are identified, assessed, managed and resolved effectively in line with Novartis processes - with root causes assessed, and lessons lea applied to future ways of working.
• Member of cross-functional teams on business process, performance or system enhancement initiatives focused on improving inspection readiness and TMF Health.
• Partner with key risk management and QA stakeholders to ensure a robust risk management framework is in place for CDGM, aligned to Novartis risk management best practices.
• Support consistent identification, evaluation and tracking of CDGM service risks, including identification of risk mitigation owners and development of robust risk mitigation plans.
• Support development of CDGM staff capabilities in relation to inspection/audit support and to embed risk-based approaches into CDGM service delivery.
• Maintain an awareness of the external regulatory environment and Novartis processes for inspection/audit support, and risk management and apply those to CDGM ways of working.

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.

The role can be based in either Ireland, UK, Switzerland, India, US (East Hanover). Our selection process will prioritize associates whose roles may be changing or may be impacted. Should you be interested a non-US listed location, please refer to requisition 363918BR to apply. Please note relocation will not be provided.

What you'll bring to the role:

• Bachelor’s degree or equivalent and relevant industry experience
• Minimum of 5 years working in clinical research and development in the pharmaceutical industry (and/or Contract Research Organizations) with specific experience in clinical documentation and/or records & information management.
• Demonstrated success in planning and executing cross functional projects.
• Strong influencing and presentation skills. Ability to communicate effectively at all levels.
• High organizational awareness, including experience working in multi-disciplinary teams, across cultures and geographies.
• Good negotiation, problem solving and conflict resolution skills; experience establishing trusted relationships with internal and external stakeholders.

#GCO #CDGM

Why Novartis?
736 million lives were touched by Novartis medicines in 2022, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!

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.

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 tas.nacomms@novartis.com 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.

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.

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

Global Drug Development

GCO GDD

USA

East Hanover, NJ

Novartis Pharmaceuticals

Research & Development

Full Time

Regular

No

No