Job was saved successfully.
Job was removed from Saved Jobs.

Job Details

RA Systems and Strategy Manager

Agriculture and Forestry

Agricultural Manager



East Hanover, New Jersey, United States

Novartis protects 766 million patients and more than 100,000 employees in over 140 countries.<br><br>Job Purpose<br>An individual contributor in the GDD Operations Regulatory Systems and Strategy group responsible for the development, implementation and support of Regulatory systems for the Novartis global product portfolio.<br><br>Major Accountabilities<br>• Act as system owner deputy for Vital/GXP applications. Provide first line systems and end user support e.g. incident management and service request management (including assessing, resolving or escalating technical issues).<br>• Liaise with GDD colleagues on matters regarding changing regulatory requirements and the related business processes, to ensure proper knowledge transfer to IT business partners for system enhancement requests.<br>• Prepare documentation such as User Requirement Specifications, Functional Specifications, administrative procedures and Working Instructions to support system implementations.<br>• Participate as key business contributor for Technology initiatives including but not limited to Systems upgrades, Validation, implementation activities and functionality enhancements.<br>• Support user training for RA end users and IT partner as required. Mentor junior level associates.<br>• Oversee and support PQ testing and Application verification activities. Develop, implement, and support innovative regulatory strategies and life-cycle management of RA systems.<br>• Manage global projects and initiatives related to Regulatory applications and business processes with minimal supervision. Contribute to external partnership, Divestments, M&A initiatives by assessing the technical capabilities of potential new external partners.<br>• Provides recommendations on the approach for the application of expert knowledge of global regulatory requirements for systems with all contributing stakeholders to ensure compliance.<br>• Identifies and investigates operational needs, problems, and opportunities, contributing to the implementation of improvements within area of responsibility.<br><br>While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to<br><br>[#video#{#400,300#}#/video#]