Regulatory Affairs Associate

Adecco Sweden AB, Medical & Science / Apotekarjobb / Stockholm
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Adecco is the largest recruiting and staffing company in the world. Adecco Life Science is one of our specialized Business Lines, which works exclusively with Staffing Services and Recruitment of personnel for the Life Science industry. Our customers are within the Pharmaceutical-, Biotech- and Medtech companies. We focus on positions within R&D, QA, QC, Clinical Research, Marketing and Sales. We are now recruiting a Labelling Associate, preferably the candidate start as soon as possible, location Stockholm.

Purpose
• To update local Nordic & Baltic data registries related to product information.
• To review and approve artworks for labels and patient information leaflets (PILs) in the Nordic & Baltic region.

Key Activities
• Review and approve artworks in EPIC
• Collect 3rd party approvals for artworks & labels
• Coordinate translation with 3rd party and Amgen translators in line with agreed priorities set with GLO, ABR and local management
• Proof-read translations
• Update clinical trial labelling forms (LRF)- Submit import licences for clinical trial supply
• Provide general technical and logistical support to senior members of LOC Regulatory group
• Complaints intake back-up for Quality Specialist

Responsibilities
The Regulatory Affairs Labelling Associate is:
• A professional role based in the local affiliate

Reports (at a minimum) to:
• Manager, Regulatory Affairs

Responsible for:
• Ensure that artworks for marketed products are accurate and approved on time.
• Ensure that clinical trial labelling forms are accurate and updated.
• Ensure that external product data bases in the Nordic & Baltic region which are related to product labelling are updated and contains accurate information.

Qualifications
• Degree in scientific discipline or relevant other experience.
• Fluency in local language plus English
• Some experience in the pharmaceutical industry and/or working in a pharmacy

Knowledge
• Working in a regulated environment
• Document management and archiving practices
• Knowledge of key aspects of the local regulatory process

What do we offer?
Adecco is the world?s largest recruitment and staffing company and our most important asset is our qualified employees. With us, and on our customer assignments, you, as a consultant, will be appreciated for your difference-making competence! Your bank of experience will grow, as will your social and professional network of contacts.

Adecco can offer you the opportunity of interesting assignments at attractive companies, of positions that perhaps never will be put on the open market.

We want you to feel good and will give you subsidies for preventive healthcare and discounts on training cards. In order for you to feel secure, you will also be covered by insurance and corporate healthcare.

Are you interested?
Then you should apply as soon as possible. The position is to be filled immediately, and, for that reason, work with recruitment is being done on a continual basis during the application period. You apply by registering on our website www.adecco.se and applying from there or click on the following link: http://www.adecco.se/pages/jobad.aspx?adid=1477184

If you have questions regarding the recruitment process, please contact Jenni Sventoft at tel. 08-598 981 29

If you have questions regarding registration on the website, please contact Candidate Support on tel.08-598 980 10.

We look forward to your application!

Publiceringsdatum
2012-02-08

Arbetstider och omfattning
Tillsvidare
Heltid

Ersättning
Fast lön

Så ansöker du
Ansökan kan tyvärr inte göras via e-post.

Företag
Adecco Sweden AB, Medical & Science

Adress
Adecco Sweden AB, Medical & Science
Box 12127
10224 Stockholm

Kontorsadress
Kungsgatan 60
Stockholm

Kontaktuppgifter
Telefonnummer: 08-598 981 20
Faxnummer: 08-59898099
E-postadress: vard@adecco.se

Jobbnummer
1152213

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