Regulatory Operations Manager to AstraZeneca Gothenburg

Poolia Göteborg AB / Apotekarjobb / Göteborg
2018-04-03
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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
• Experience of system administration for validated applications within a regulated environment.
• Experience from analysing 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.


Who you are
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 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

Publiceringsdatum
2018-04-03

Ersättning
Fast månads- vecko- eller timlön

Så ansöker du
Sista dag att ansöka är 2018-04-09
Ange följande referens när du ansöker: 49691
Klicka på denna länk för att göra din ansökan

Företag
Poolia Göteborg AB

Adress
Poolia Göteborg AB
Kungsgatan 42
41115 Göteborg

Kontorsadress
Kungsgatan 42

Jobbnummer
4058791

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