Regulatory Documentation Systems Manager
Experis IT Huvudkontor / Datajobb / Göteborg
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This is a one year consultant assignment at AstraZeneca. If the description below matches your competences, please apply with an english CV.
Main Tasks
ANGEL is a suite of tools used by GRAPSQA (Global Regulatory Affairs, Patient Safety, and Quality Assurance), AZ Clinical, and other functions within AZ/MedImmune to support document management, registration tracking, and submission publishing.
FirstDoc (aka ANGEL/FirstDoc) is the Electronic Document Management System (EDMS) component of ANGEL and is used for managing documents for regulatory submissions to health authorities. ANGEL/FirstDoc is a CSC FirstDoc based front-end/ EMC Documentum back-end platform.
The ANGEL Business Specialist (ABS) team supports GRAPSQA, Clinical, and Regulatory MC users of ANGEL/FirstDoc. The formal name of the ABS position is Regulatory Documentation Systems Manager (RDSM).
Reporting to the Director/ Group Manager, the RDSM acts as a FirstDoc Subject Matter Expert (SME) and is responsible for facilitating effective and compliant use of ANGEL/FirstDoc in the following areas:
FirstDoc Administration Activities
• Maintaining ANGEL/First Doc access and security across GRAPSQA and Clinical owned documentation
• Apply appropriate permissions sets to folders and documents to limit access to the necessary level
• Submit requests to create new permission sets in ANGEL/FirstDoc
• Maintain membership of groups included within permission sets in line with business need.
• Perform basic trouble-shooting of technical issues related to FirstDoc as reported by the customer base
User Support
• Provide support for users of ANGEL/First Doc, and determine if issues or questions reported by the users relate to FirstDoc functionality, business processes or technical errors - if the latter, then raising an incident with IS Support on the user's behalf, or advising the user on how to raise the incident with IS Support.
• Practively respond to users requests
• Provide desk-side support
• Assign relevant ANGEL/First Doc training within the formal Learning Management System
• Managing user access to ANGEL/First Doc, including authorising new user requests
• Support changes to access levels in ANGEL/FirstDoc
• Establish when it is critical for ANGEL/First Doc to be available for users based on business need, and submitting these dates to ANGEL Governance.
Business Process Knowledge
• Translating clinical and/or regulatory knowledge into business processes as it pertains to FirstDoc
• Notifying the Lead ABS of any requirement to change or add metadata and/or additions/modifications/deletions to dictionaries within FirstDoc.
• Raising ANGEL/First Doc change requests on behalf of the users, ensuring that: all such requests represent a valid, global requirement; all necessary information is captured to allow the request to be processed through the ANGEL/First Doc change management process; and progress in respect of the change is monitored and fed back to the business.
Training
• Providing face-to-face and web-ex training to ANGEL/FirstDoc users.
Vem är du?
A suitable background for this position is an IT background, specifically experiences with FirsDoc and experiences from IT support. The FirstDoc experiences or an IT support background is the most essential ones. Other electronic documents management systems besides FirstDoc are also acceptable.
Regulatory knowledge is also very good to have.
Essential
• Knowledge of First Doc functionality, policies, procedures and processes.
• Expertise in customer service and user support for software systems
• Comfort and experience giving training on software systems, both in person and via web-ex (or other such applications)
• Knowledge of patient safety, clinical, regulatory processes and documentation
• Experience of working in geographically diverse global teams, and dealing with cultural differences.
• Fluent in Swedish as well as English, orally and written.
Varaktighet, arbetstid
100% Enligt överenskommelse
Publiceringsdatum2016-02-29ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2016-03-04
Klicka på denna länk för att göra din ansökanKontaktSabine Törn
FöretagExperis IT Huvudkontor
AdressExperis IT Huvudkontor
Klarabergsgatan 29
11181 Stockholm
KontorsadressKlarabergsgatan 29
Jobbnummer 2696811
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