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Experis IT erbjuder kompetensförsörjning av chefer och specialister inom IT via konsultverksamhet, rekrytering och projektlösningar. Genom att kombinera vår branscherfarenhet med vår kunskap om människans potential får vi såväl individer som verksamheter att växa och utvecklas. Experis IT finns på ett 30-tal orter i Sverige och i mer än 50 länder världen över.
This is a consultant assignment at AstraZeneca, which means you will be hired by Experis but work at AstraZeneca.
Candidate Focus & Challenge
The System Support Manager plays a key role in controlling access, maintaining security, and facilitating the efficient and effective use of Regulatory Systems supported by ISSA.
Of primary importance is ANGEL, which is a suite of applications including:
• FirstDoc for management of regulatory documents
• Register for tracking registrations and products
• eCTDXPress and Publisher for compiling and submitting to regulatory agencies.
Other systems and applications include:
• SAFE: Digital identity and signature
• Oracle-Empirica: Signal management system
• Ariadne: Enables aggregate analysis and reporting of safety data
In addition, this role applies specialized knowledge relating to learning, support and enablement, to ensure that customers gain full value from these systems.
• Deliver high quality expertise and services relating to the systems identified above, ensuring that prioritized requirements and strategic goals of customers in GRAPSQA and the wider enterprise are recognised and supported.
• Maintain and regularly monitor access and security in accordance with agreed procedures and conventions.
• Provide relevant process and system-related guidance and support for deliverables, where required.
• Manage ISSA systems communication methods, e.g. portals, SharePoint.
• Provide expert input to the ongoing development and implementation of the GRAPSQA IS portfolio, ensuring quality, efficient and timely delivery of assigned activities.
• Provide expertise to project teams to ensure that solutions are supported by robust learning and support interventions that will build competency/capability in the effective use of the solution and demonstrate compliance with relevant legal and/or regulatory requirements, e.g. GxP.
• Collaborate with other experts across GRAPSQA or more widely (e.g. Global Medicines Development, AstraZeneca IS, external partners) who are involved in the design, development and delivery of IS-related solutions, or related business deliverables such as policies, procedures, processes and guidance.
Who are you
Bachelor’s degree or a proven track record of equivalent experience in a similar role.
Minimum approximately three years’ experience of system administration for a validated application within a regulated environment, preferably within the pharmaceutical/biotech industry. Preferred system experience:
• Document management systems
• Publishing tools
• Submission management / registration tracking tools
• Safety databases
Minimum approximately three years’ experience of delivering system support and/or training to end users; for example
• Managing support mailbox
• Delivering workshops and instructor-led sessions
• Authoring user resource material such as job aids, cue cards and guidance documents
• Development of e-learning or classroom training content
• Administering Learning Management System
Experience of change control management and administration.
Knowledge of the drug development process, in particular, regulatory documentation, submission, publishing and approval processes.
Experience of working in geographically diverse global teams and dealing with cultural differences
Experience/Capability with supporting tools such as SharePoint, Excel, Access, OneNote, Visio, PowerPoint, Project, Articulate, Captivate, WebEx
• Able to deal with a rapidly changing environment
• Able to identify opportunities to lead change through innovation – seeking continuous improvement
• Team player – able to share responsibilities with colleagues and offer/accept constructive feedback
Please provide your CV in English.
If you have questions, contact [email protected]