Regulatory Operations Manager to AstraZeneca Gothenburg
Dfind Science & Engineering AB / Apotekarjobb / Göteborg
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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 consultant assignment lasting until 2019-06-30.
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.
Business: Dfind Science & Engineering
City: Gothenburg
Deadline for applications: 2018-12-10. Selection is on-going and interviews will be held continuously which means the position can be filled before deadline. Please make sure to send in your application at your earliest convenience!
For more information contact: Malin Wåhlberg
malin.wahlberg@dfind.se or Birgitta Nyström
birgitta.nystrom@dfind.se.
Please keep in mind, e-mail applications will not be considered. Register your profile at Dfind Science & Engineering's webpage and send in your application there.
Organization/Business description:
Dfind Science & Engineering is a recruitment and consulting company within science and engineering. All our consultant managers and recruitment consultants have an education and work experience within the respective field. In combination with extensive knowledge of staff issues and solid experience of recruitment, this means that we understand our clients' need for both flexibility and the right skills.
Dfind Science & Engineering is since 2016 part of Randstad Group. With over 600 000 employees in over 40 countries Randstad is the world's second largest company within recruiting and staffing.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2018-12-04ErsättningFast lön
Så ansöker duSista dag att ansöka är 2018-12-14
Ange följande referens när du ansöker: 201189191
Klicka på denna länk för att göra din ansökanKontaktMalin Wåhlberg
malin.wahlberg@dfind.seFöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Södra Hamngatan 35
41110 GÖTEBORG
KontorsadressSödra Hamngatan 35, 41110 GÖTEBORG
Jobbnummer 4491574
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