386084BR
Jan 18, 2024
USA
About the Role
Location: #LI-Hybrid ; #LI-Distance Worker
Clinical Document Governance Management (CDGM) is accountable for strategy and delivery of clinical document management (CDM) systems, processes, standards and operations of CDM services (including Trial Master File management (TMF), clinical submission readiness, record retention and archiving, Good Documentation Practice capability build) across Novartis globally. In addition, CDGM is driving the transformation of TMF at Novartis, through the introduction and adoption of new technologies, processes and ways of working.
This individual contributor role is accountable for coordinating or supporting Health Authority Inspection, internal audits and other quality related issues, as well as risk management, in relation to clinical document management at Novartis.
Key Responsibilities:
• 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 efficiency checks, monitoring of CAPA execution to ensure results are achieved in line with desired improvement and agreed timeframes.
• Identify and be responsible for 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 partners to ensure Quality Issues and Quality Events are identified, assessed, handled and resolved optimally 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 improvement initiatives focused on improving inspection readiness and TMF Health.
• Partner with key risk management and QA customers to ensure a robust risk management framework is in place for CDGM, aligned to Novartis risk management standard processes.
• 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 ideal location for this role is the East Hanover, NJ site but a distant working arrangement may be possible in certain states. Distant workers are responsible for the cost of home office expenses and periodic travel/lodging to the East Hanover, NJ site, as determined necessary by hiring manager. This position will require minimal travel as defined by the business (domestic and or international).
Clinical Document Governance Management (CDGM) is accountable for strategy and delivery of clinical document management (CDM) systems, processes, standards and operations of CDM services (including Trial Master File management (TMF), clinical submission readiness, record retention and archiving, Good Documentation Practice capability build) across Novartis globally. In addition, CDGM is driving the transformation of TMF at Novartis, through the introduction and adoption of new technologies, processes and ways of working.
This individual contributor role is accountable for coordinating or supporting Health Authority Inspection, internal audits and other quality related issues, as well as risk management, in relation to clinical document management at Novartis.
Key Responsibilities:
• 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 efficiency checks, monitoring of CAPA execution to ensure results are achieved in line with desired improvement and agreed timeframes.
• Identify and be responsible for 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 partners to ensure Quality Issues and Quality Events are identified, assessed, handled and resolved optimally 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 improvement initiatives focused on improving inspection readiness and TMF Health.
• Partner with key risk management and QA customers to ensure a robust risk management framework is in place for CDGM, aligned to Novartis risk management standard processes.
• 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 ideal location for this role is the East Hanover, NJ site but a distant working arrangement may be possible in certain states. Distant workers are responsible for the cost of home office expenses and periodic travel/lodging to the East Hanover, NJ site, as determined necessary by hiring manager. This position will require minimal travel as defined by the business (domestic and or international).
Diversity & Inclusion / EEO
We 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.
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 let us know the nature of your request, your contact information and the job requisition number in your message:
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 let us know the nature of your request, your contact information and the job requisition number in your message:
- Novartis: e-mail [email protected] or call +1 (877)395-2339
- Sandoz: e-mail [email protected] or call: +1-609-422-4098
Role Requirements
Key Requirements:
• Bachelor’s degree or equivalent and relevant industry experience
• 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 efficiency checks, monitoring of CAPA execution to ensure results are achieved in line with desired improvement and agreed timeframes.
• Identify and be responsible for 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 partners to ensure Quality Issues and Quality Events are identified, assessed, handled and resolved optimally 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 improvement initiatives focused on improving inspection readiness and TMF Health.
• Partner with key risk management and QA customers to ensure a robust risk management framework is in place for CDGM, aligned to Novartis risk management standard processes.
• Support consistent identification, evaluation and tracking of CDGM service risks, including identification of risk mitigation owners and development of robust risk mitigation plans.
Why Novartis:
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and 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 $130,400 and $195,600/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, 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 hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
• Bachelor’s degree or equivalent and relevant industry experience
• 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 efficiency checks, monitoring of CAPA execution to ensure results are achieved in line with desired improvement and agreed timeframes.
• Identify and be responsible for 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 partners to ensure Quality Issues and Quality Events are identified, assessed, handled and resolved optimally 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 improvement initiatives focused on improving inspection readiness and TMF Health.
• Partner with key risk management and QA customers to ensure a robust risk management framework is in place for CDGM, aligned to Novartis risk management standard processes.
• Support consistent identification, evaluation and tracking of CDGM service risks, including identification of risk mitigation owners and development of robust risk mitigation plans.
Why Novartis:
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and 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 $130,400 and $195,600/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, 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 hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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
Development
GCO GDD
USA
East Hanover, NJ
Novartis Pharmaceuticals
Research & Development
Full Time
Regular
No
386084BR