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For AstraZeneca we are now looking for a System Support Manager in the field of Regulatory Affairs and Patient Safety for a consultant assignment that will start in March and go on for one year with possibility for extension.
Interviews and selections are held on an ongoing basis so please apply today!
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.
Your primary task will be to work in 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
- SAFE: Digital identity and signature
- Oracle-Empirica which is a Signal management system
- Ariadne to Enable aggregate analysis and reporting of safety data
- apply specialized knowledge relating to learning, support and enablement
- ensure that customers gain full value from these systems
- to deliver expertise and services relating to the systems
- ensure that prioritized requirements of customers in GRAPSQA are recognised and supported
- maintain and regularly monitor access and security
- provide relevant process and system-related guidance
- support for deliverables
- manage ISSA systems communication methods
- provide expert input to the ongoing development and implementation of the GRAPSQA IS portfolio
- provide expertise to project teams in the effective use of the solution and demonstrate compliance with relevant legal and/or regulatory requirements
- collaborate with other experts across GRAPSQA or more widely who are involved in the design, development and delivery of IS-related solutions
We think that you have a Bachelor’s degree or a proven track record of equivalent experience in a similar role. You have at least three years experience of system administration for a validated application within a regulated environment, preferably within the pharmaceutical industry. Preferred system experience is Document management systems, Publishing tools, Submission management and Safety databases. You have additionally at least 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 and Administering Learning Management System. You have experience of change control management and administration and 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 is preffered as well as capability with supporting tools such as SharePoint, Excel, Access, OneNote, Visio, PowerPoint, Project, Articulate, Captivate and WebEx is essential.t
You are able to deal with a rapidly changing environment, to identify opportunities to lead change through innovation seeking continuous improvement. You are aeam player able to share responsibilities with colleagues and offer/accept constructive feedback.
We take good care of our consultants and we offer social activities, as well as help in planning your future career. Your consultant manager is well experienced from your field, and knows how to get the most out of your assignment.
As a Poolia employee, you are included in the requirements concerning agreements on terms of employment by Unionen. Moreover, you get a grant for working out at your choice of place. You are also covered by a health insurance.
Poolia Life Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you.
Working as a consultant suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you’re looking for a world of exciting assignments and new contacts, you’ll like being a consultant.
AstraZeneca is a major international healthcare company engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. But we are more than one of the world’s leading pharmaceutical companies - at AstraZeneca, we are proud to have a unique culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
Please apply by registering your CV here on our website. Click on the "Ansök" button to the right of this advertisement. It is our recommendation that you register as much information as possible and that you attach a complete CV-document. Please check that your correct e-mail adress is registered.
Poolia is a registered staffing agency, meaning that we comply with the requirements set by Bemanningsföretagen - the Swedish Association of Staffing Agencies.