Regulatory Operations Manager to AstraZeneca, Gothenburg
Modis Sweden AB / Kemiingenjörsjobb / Göteborg
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hela Sverige Modis Life Science is looking for a Regulatory Operations Manager to AstraZeneca, Gothenburg.
The consultant assignment will start as soon as possible and proceed until 2018-08-31.
Welcome with your application no later than March 16th!
Would you like the opportunity to work in a global team environment? Do you have experience of working with end-to-end document and submission publishing? Then this might be the right role for you!
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 for one consultant for the role as Regulatory Operations Manager (ROM) to our site in Gothenburg, Sweden.
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.
Essential Requirements
* Ability to provide global expertise on requirements for electronic document management, submission compilation and publishing.
* 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.
* Demonstrate an understanding of the characteristics in building successful supplier relationships, monitors Service Level Agreements (SLAs) and manages routine quality, resource and performance issues to resolution.
* Demonstrated ability to work independently and to set and manage priorities, resources, performance targets and project initiatives in a global environment.
* Ability to assess data, documentation and processes for regulatory impact/compliance with relevant regulations and guidance and clearly communicate requirements to immediate stakeholders.
* Ability to use project management principles and techniques.
* Excellent English written and verbal communication skills.
Desirable Requirements
* Experience from planning, preparation and delivery of regulatory submissions throughout the product 's life cycle.
* Experience from analysing queries from the user community to identify improvement opportunities in Systems, Cue Cards, Training Materials and business processes.
* Experiences from providing support in assisting users with questions related to end-to-end document and submission publishing.
* Experience in pharmaceutical/medical industry and/or knowledge of the drug development process, product life-cycle and contents/formatting of regulatory submissions.
* Experience of system administration for validated applications within a regulated environment.
* 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.
Varaktighet, arbetstid
Heltid Visstid
Publiceringsdatum2018-03-08ErsättningFast lön
Så ansöker duSista dag att ansöka är 2018-03-16
Klicka på denna länk för att göra din ansökanKontaktNalin Yilmaz
Nalin.Yilmaz@modis.seFöretagModis Sweden AB
AdressModis Sweden AB
Postgatan 28
41110 Göteborg
KontorsadressPostgatan 28
Jobbnummer 4008395
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