US-TX, Senior Global Technical Regulatory Business Administrator 218727BR-MZ
Senior Global Technical Regulatory Business Administrator
Global Drug Development
REG AFFAIRS GDD
Fort Worth, TX
Research & Development
The Senior Global Technical Regulatory Business Administrator (SrGTROBA) will manage administration of and provide support for DRA owned computerized systems, including but not limited to Documentum related platforms, secure and qualified file shares, submission publishing applications, eCTD validation/review platforms and CD burning hardware & software. The SrGTROBA will investigate incidences and provide root cause analysis.
Provide first line support for DRA end users, e.g. incident management and service request management. This includes tasks such as resolving or escalating technical issues, as well as user management. Facilitate communication and collaboration between DRA Ops and IT partners in matters pertaining to above mentioned applications, such as regular system updates, enhancement requests and summarizing activities for reporting to management with some supervision. Liaise with DRA Operations Standards & Strategy on matters regarding changing regulatory requirements and the related business processes, to ensure proper knowledge transfer to IT Partners for system enhancement requests. Participate in validation and implementation activities for system upgrades and functionality enhancements. Develop or comment on documents such as User Requirement Specifications, Functional Specifications, administrative procedures and Working Instructions, and ensure implementation as needed. Ensure good global communication and interaction with DRA Ops TRO colleagues worldwide by asking for global input on above mentioned documents. Provide user training for DRA end users. Participate in other department activities / initiatives as required.
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 any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Bachelor's degree in computer science or business management (or equivalent in education and experience), preferably with a 4-7 year experience ( SrGTROBA I 3-5 years, SrGTROBA II 4-7 years) working w English Good interpersonal skills, with an ability to effectively manage customer relationships with internal and external partners. A working knowledge of the PC desktop environment, Microsoft suite of products, Windows, Adobe Acrobat, as well as CD Burning and Scanning. Knowledge and experience with eCTD submissions as well as advanced knowledge of xml is highly desirable. Training and experience in 21 CFR Part 11 requirements for electronic records, electronic signatures. Good knowledge of the different Health Authority submission formats, the overall drug development process, and the related document requirements. Ability to work under pressure of time; highly motivated, but flexible, with effective prioritization of workload. Ability to run a small project team.
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