Address
Form of workAbout 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.
The Submission Readiness Document Manager is an individual contributor. Responsible for readiness of clinical documents included in regulatory submissions to meet eCTD requirements and to support rapid, accurate and timely submissions to health authorities.
Key Responsibilities:
• 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.
• Performs 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 partners (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 partners 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 partners
• Provides Audit/Inspection support, contributes to root cause analysis identification and creation/delivery of CAPAs.
**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).
Role Requirements
Essential Requirements:
• Education: Bachelor's degree in Life Sciences/healthcare/pharmacy/information management and relevant industry experience.
• Detailed knowledge of clinical document management processes.
• Advanced knowledge of clinical documentation standard process 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.
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 $118,400 and $177,600/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 hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
EEO Statement
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:
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.
The Submission Readiness Document Manager is an individual contributor. Responsible for readiness of clinical documents included in regulatory submissions to meet eCTD requirements and to support rapid, accurate and timely submissions to health authorities.
Key Responsibilities:
• 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.
• Performs 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 partners (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 partners 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 partners
• Provides Audit/Inspection support, contributes to root cause analysis identification and creation/delivery of CAPAs.
**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).
Role Requirements
Essential Requirements:
• Education: Bachelor's degree in Life Sciences/healthcare/pharmacy/information management and relevant industry experience.
• Detailed knowledge of clinical document management processes.
• Advanced knowledge of clinical documentation standard process 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.
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 $118,400 and $177,600/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 hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
EEO Statement
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:
- Novartis: e-mail us.reasonableaccommodations@novartis.com or call +1 (877)395-2339
- Sandoz: e-mail reasonable.accommodations@sandoz.com or call: +1-609-422-4098
