Regulatory Documentation Systems Manager for AstraZeneca
AstraZeneca / Proffice Link AB / Datajobb / Göteborg
2016-02-26
Observera att sista ansökningsdag har passerat.
➡️ Klicka här för den senare publicerade platsannonsen "Regulatory Documentation Systems Manager for AstraZeneca" (publicerad 2016-03-24) ⬅️
Visa alla datajobb i Göteborg,
Mölndal,
Partille,
Kungälv,
Lerum eller i
hela Sverige Visa alla jobb hos AstraZeneca / Proffice Link AB i Göteborg,
Mölndal,
Södertälje,
Stockholm eller i
hela Sverige For AstraZeneca we are now looking for a Regulatory Documentation Systems Manager for a consultant assignment for one year with possibility for extension.
Interviews and selections are held continously so please apply today!
Publiceringsdatum2016-02-26Dina arbetsuppgifterANGEL is a suite of tools used by 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).
You will be working with:
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.
Utbildning/erfarenhet
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.
Desirable
• Experience of system administration for a validated application within a regulated environment.
• Knowledge of the drug development process, in particular, regulatory documentation, submission, publishing and approval processes.
• Building relationships across, cultures, functions and disciplines to deliver a quality service
• Excellent interpersonal skills
• Delivery and customer focused
• Good organisational skills
Varaktighet, arbetstid
100%. Tillträde: Omgående Visstidsanställning
ErsättningMånadslön
Så ansöker duSista dag att ansöka är 2016-03-10
Ange följande referens när du ansöker: 661263
Klicka på denna länk för att göra din ansökanFöretagAstraZeneca / Proffice Link AB
AdressAstraZeneca / Proffice Link AB
Kungsgatan 57 A, Box 207
10124 Stockholm
KontorsadressKungsgatan 57 A, Box 207
Jobbnummer 2694349
Observera att sista ansökningsdag har passerat.