Regulatory Operations Manager to AstraZeneca Gothenburg
Poolia Göteborg AB / Apotekarjobb / Göteborg
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hela Sverige We are now looking for a talented Regulatory Operations Manager to join AstraZeneca Gothenburg. The consulting assignment will start in January 2019 after agreement and lasting until 2019-06-30. If you are interested, apply now!
About the consulting 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 now have a temporary position as a Regulatory Operations Manager 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 2019-06-30.
about you
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.
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 AstraZeneca
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.
Warmly welcome with you application!
Varaktighet, arbetstid
Heltid Sex månader eller mera
Publiceringsdatum2018-12-04ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2018-12-11
Ange följande referens när du ansöker: 52115
Klicka på denna länk för att göra din ansökanFöretagPoolia Göteborg AB
AdressPoolia Göteborg AB
Kungsgatan 42
41115 Göteborg
KontorsadressKungsgatan 42
Jobbnummer 4491896
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