Regulatory Operations Manager to AstraZeneca Gothenburg

Modis Sweden AB / Läkarjobb / Mölndal
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Modis is a staffing & recruiting company and is part of the Adecco Group, the world 's leading HR-solutions provider across 60 countries. This scale and scope ensures Modis is truly a global community. Our mission is to be the Leading Professional Services Company by finding the right match between you as a candidate and you as a customer. We are a team with various and complementary backgrounds within Life Science, Engineering and Technology. We can ensure that we understand our customer needs and we can ensure that we understand the competence-profiles of our applicants and candidates.

We are now seeking for a Regulatory Operations Manager to AstraZeneca Gothenburg.

About the customer

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.

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.

Please submit your application in English today, or by latest 2018-12-11 by attaching your CV and personal letter (interviews are held continuously).

If you have any questions about the assignment, do not hesitate and contact Markus Dahl (markus.dahl@modis.se).

Varaktighet, arbetstid
Heltid Full time (40h/week), 6 month assignment

Publiceringsdatum
2018-12-04

Ersättning
Fast lön

Så ansöker du
Sista dag att ansöka är 2018-12-11
Klicka på denna länk för att göra din ansökan

Kontakt
Markus Dahl

Företag
Modis Sweden AB

Adress
Modis Sweden AB
Hamngatan 13
11146 Stockholm

Kontorsadress
Hamngatan 13

Jobbnummer
4491455

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