Regulatory Documentation Systems Manager to AstraZeneca
Pema People AB / Datajobb / Göteborg
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We are now looking for a Senior Research Scientist with extensive experience from Stem Cell Research for an exciting assignment at AstraZeneca in Gothenburg. With the right profile and a lot of passion, this might be the start of a fruitful employment at Pema Engineering & Science.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
The Arena
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).
Tasks and responsibilities/The role:
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/FirstDoc 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/FirstDocEstablish 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/FirstDoc 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.
Education, Qualifications, Skills and Experience
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
• Customer service/supportFlexibility and adaptability
• Ability to deal with ambiguity and change
Soft skills and key factors
• Customer service/support
• Flexibility and adaptability
• Ability to deal with ambiguity and change
Are you the perfect match?
If you have any questions regarding the assignment, please contact Business Area Manager, Karin Lyckemalm at
karin.lyckemalm@pemapeople.se .
You apply by register below and attach CV and cover letter.
Last applicxation day is 2016-03-03, however selection is done continuously.
We are looking forward to receiving your application and wish you a splendid day!
Pema People AB is staffing and recruitment Company that has been active since 1997. Pema People AB is a company in constant development and since 2016 we are present in Gohenburg. We match the best people to interesting companies and assignments. We offer our employees maximum experience in short time.
Pema Engineering & Science has extensive experience from both staffing and science. You can feel Confident in that we understand your business and the challenges you may face. We offer our staff a unique and solid employment solution, which forms the basis for a long-term cooperation.
Varaktighet, arbetstid
Heltid Length of the assignments is more 12 months. Desired start date: asap Pema Engineering & Science offer permanent employment for choosen candidates
Publiceringsdatum2016-02-26ErsättningFixed monthly salary
Så ansöker duSista dag att ansöka är 2016-03-03
Ansöker gör du genom att använda länken nedan.
Klicka på denna länk för att göra din ansökanKontaktKarin Lyckemalm
FöretagPema People AB
AdressPema People AB
Ektorpsgatan 6
60337 Norrköping
KontorsadressEktorpsgatan 6
Övriga kontaktuppgifter Jobbnummer 2694125
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