Regulatory Information Managers to AstraZeneca, Gothenburg!

Adecco Sweden AB / Läkarjobb / Göteborg
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Adecco Life Science is now looking for 3 Regulatory Information Managers to AstraZeneca Gothenburg! We are looking for you who have regulatory

The consultant assignments will start in February and proceed for 1 year.

Welcome with your application no later than January 18th.

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.

The Arena:
Would you like the opportunity to work in a global team environment? Do you have experience of working with Regulatory Information? Are you up for a new challenge in the ever-changing environment called RIMs?

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 now looking for 3 consultants for the role as Regulatory Information Manager, to join our team for a 12 month assignment.

Tasks and responsibilities / The Role:
As Regulatory Information Manager you will be an expert in end-to-end tracking and documentation, which includes set-up, follow up and documentation of regulatory submissions and approval information. As a Regulatory Information Manager, you will also be an expert in understanding Health Authority legislation interpretation as well as the regulatory requirements with regard to licenses and clinical trials aspects of tracking and life-cycle management.

To be successful in this role you have to show a demonstrated ability to work collaboratively in a global team environment and have good project management skills. You need the ability to work independently and to set and manage priorities, resources, performance targets and project initiatives in a global environment. It is important that you can 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.

Essential Requirements

* Minimum 1 year hands-on experience with tracking of regulatory information.
* University degree or equivalent experience in life sciences or technical field.
* Ability to provide global expertise on requirements for tracking of regulatory submissions and approvals.
* 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.
* Experience from planning of large and complex business activities.
* Demonstrates a broad working knowledge of process improvement methodologies, tools, techniques and their application.
* Excellent English written and verbal communication skills.

Desirable Requirements

If you have previous experience of system administration for validated applications within a regulated environment this would be an advantage as well as knowledge of AstraZeneca submission, publishing, approval processes, tools and standards. Previous experience in using ANGEL applications is also qualifying. The successful candidate have good problem and conflict resolution skills and the ability to see changes as an opportunity to improve performance and add value to the business.

What do we offer?
Adecco Life Science is a specialized Business Line within Adecco. We work exclusively with Staffing Services and Recruitment of personnel within the Life Science industry. Our expertise lies within all areas of Life Science such as R&D, Production, Quality Assurance, Clinical Research, Regulatory Affairs, Medical Affairs, Marketing & Sales and many more. Our customers are companies, of different sizes, within the Pharmaceutical-, Biotech- and Medtech- industries. As the largest recruiting and staffing company in the world our most valuable assets are our consultants. With us, you as a consultant will be appreciated for your difference-making competence within Life Science!

Adecco Life Science can offer you the opportunity of interesting assignments and positions at attractive companies that perhaps never will be put out on the open market! For your security as a consultant, you are covered by our collective agreement and by insurance and corporate healthcare. We also want you to stay healthy and therefore offer you healthcare contributions and discounts on training cards. We arrange social activities continuously where you are able to share your experiences with our other consultants.

Are you interested?
Then you should apply as soon as possible. The position is soon to be filled and therefore work with recruitment is being done on a continual basis.

Unfortunately we cannot accept applications through e-mail, but if you have questions regarding the position contact Nalin Yilmaz, nalin.yilmaz@adecco.se

We look forward to your application!

Varaktighet, arbetstid
Heltid Visstid

Publiceringsdatum
2017-12-21

Ersättning
Fast lön

Så ansöker du
Sista dag att ansöka är 2018-01-19
Klicka på denna länk för att göra din ansökan

Kontakt
Nalin Yilmaz nalin.yilmaz@adecco.se

Företag
Adecco Sweden AB

Adress
Adecco Sweden AB
Kungsgatan 60
10224 STOCKHOLM

Kontorsadress
Kungsgatan 60

Jobbnummer
3867602

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