CSR Appendices Oversight Manager
CSR Appendices Oversight Manager
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$ 114100 - 195600
1 Vacancy
Job Description
Band
Level 4Job Description Summary
This position will be located at East Hanover NJ site and will not have the ability to be located remotely.Please note that this role would not provide relocation and only local candidates will be considered.
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.
#LIHybrid
Key Responsibilities:
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 crossfunctional stakeholders (e.g. Regulatory Writing & Submissions Regulatory Affairs Trial Management etc.) on the planning preparation and delivery of highquality 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.
Job Description
Requirements:
- Bachelors degree in lifesciences/healthcare/pharmacy/information management and relevant industry experience. Preferred
- Thorough knowledge of clinical document management processes
- Advanced knowledge of clinical documentation practice guidelines & principles (Good Documentation Practice Data integrity ICH eCTD andFDA Portable Document formatting specifications (PDF) guidance)
- Experience of authoring compilation and formatting of CSR appendices according to ICH E3
- Minimum of 5 years in clinical development/clinical operations or similar business
Area Preferred
- Prior 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
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $114100 and $195600/year; however while salary ranges are effective from 1/1/25 through 12/31/25 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 signon 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 atwill 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.
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. 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 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
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an email to call 1 (877)and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
Skills Desired
Budget Management Clinical Trials Negotiation Skills Process Improvement Project Planning Vendor Management Waterfall ModelRequired Experience:
Manager
Employment Type
Full-Time
