Regulatory Operations Manager to AstraZeneca Gothenburg
Poolia Göteborg AB / Apotekarjobb / Göteborg
2018-03-08
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hela Sverige 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! We are currently looking for one consultant for the role as Regulatory Operations Manager (ROM). The position is a temporary assignment lasting until 2018-08-31. Next step, apply today!
about the consultant assignment
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 position is a temporary assignment lasting until 2018-08-31.
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.
Who you are
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 Poolia & AstraZeneca
Poolia take good care of our consultants and we offer social activities, as well as help in planning your future career. Your consultant manager is well experienced from your field, and knows how to get the most out of your assignment. As a Poolia employee, you are included in the requirements concerning agreements on terms of employment by Unionen. Moreover, you get a grant for working out at your choice of place. You are also covered by a health insurance.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. AstraZeneca is one of the world's leading pharmaceutical companies. At AstraZeneca, we promote a culture that inspires innovation and collaboration.
Next step, apply today!
Varaktighet, arbetstid
Heltid Sex månader eller mera
Publiceringsdatum2018-03-08ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2018-03-16
Ange följande referens när du ansöker: 49691
Klicka på denna länk för att göra din ansökanFöretagPoolia Göteborg AB
AdressPoolia Göteborg AB
Kungsgatan 42
41115 Göteborg
KontorsadressKungsgatan 42
Jobbnummer 4008657
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