Regulatory Operations Manager
Modis Sweden AB / Läkarjobb / Mölndal
2018-04-12
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hela Sverige Modis Life Science is looking for a Regulatory Operations Manager to AstraZeneca in Gothenburg!
The Consultant assignment will start as soon as possible and proceed until 2018-12-31.
Welcome with your application no later than 2018-04-17!
Regulatory Operations Manager to AstraZeneca Gothenburg
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We are currently looking to hire a Regulatory Operations Managers to our site in Gothenburg, Sweden for an approximately half year assignment.
The Regulatory Operations Manager (ROM) is an expert in end-to-end document and submission publishing. The ROM is also an expert in understanding Health Authority requirements as well as the regulatory requirements regarding technical and formatting aspects of global regulatory submission publishing.
The position is a temporary assignment lasting until 2018-08-31.
Essential Requirements
• Experience of system administration for validated applications within a regulated environment.
• Experience from analyzing queries from the user community to identify improvement opportunities in Systems, Cue Cards, Training Materials and business processes.
• Demonstrated ability to work collaboratively in a global team environment and to have good project management skills.
• Demonstrates a broad working knowledge of process improvement methodologies, tools, techniques and their application.
• Excellent English written and verbal communication skills.
Desirable Requirements
• Demonstrated ability to work independently and to set and manage priorities, resources, performance targets and project initiatives in a global environment.
• Ability to use project management principles and techniques.
• Experience from planning, preparation and delivery of regulatory submissions. Providing support to users with questions related to document and submission publishing.
• Experience from evaluating regulations, guidelines and technical specifications related to publishing/submission processes.
• Experience in pharmaceutical/medical industry and/or knowledge of the drug development process, product life-cycle and contents/formatting of regulatory submissions.
• Experience from electronic document managements systems.
• Good problem and conflict resolution skills.
About Modis
We are constantly striving to support our customers and consultants to become successful. As a consultant, you are our top priority and when you need us, we will be there for you.
We will include you in our business and to our customers. You are our most important asset and for us to stay ahead you will take an active part in our business development and our offers to the market.
By becoming our colleague, your daily life as a consultant will be shifting with different assignments and projects in a variety of industries, systems and environments. Your experience will increase as well as your social and professional network. As a consultant, you are covered by collective agreements, insurance, occupational healthcare, healthcare and discounts on training cards. We believe in connecting people so having regularly social activities is key for us.
Modis delivers a wide range of services and competencies within IT, Engineering and Life Science. Our services are characterized by speed, simplicity and quality. Modis is represented in the United States, Canada, Europe with over 100 offices and with more than 35,000 colleagues on assignments each day.
Are you interested?
Then you should apply as soon as possible. The position is soon to be filled and therefore work with recruitment is being done on a continual basis.
If you have questions regarding the position please contact:
Nalin Yilmaz
nalin.yilmaz@modis.se 073 684 70 51
Anders Olsson
anders.olsson@modis.se 073 684 72 48
Varaktighet, arbetstid
Heltid Visstid
Publiceringsdatum2018-04-12ErsättningFast lön
Så ansöker duSista dag att ansöka är 2018-04-18
Klicka på denna länk för att göra din ansökanKontaktNalin Yilmaz
Nalin.Yilmaz@modis.seAnders Olsson Anders.Olsson@Modis.se
FöretagModis Sweden AB
AdressModis Sweden AB
Postgatan 28
41110 Göteborg
KontorsadressPostgatan 28
Jobbnummer 4079651
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