Regulatory Affairs Assistant – Proofreader

Regulatory Affairs Assistant
We are now looking for a Regulatory Affairs Assistant - Proofreader for an assignment at AstraZeneca. You need to be fluent in English language with excellent communication skills, both verbally and written.

Business: Dfind Science & Engineering

City: Göteborg

The Global Labeling Operations team is responsible for the regulatory role as part of the process for coordination, development and implementation of new and revised printed labeling for assigned commercial products.  

The Labeling Operations Proofreader/Reg Assistant is responsible for supporting development and implementation of new and revised printed labeling for assigned products, primarily in a proofreading capacity.  Depending on ability, the candidate may also provide other operational support to ensure labeling document integrity and delivery.



The role

Under the direction of Labeling personnel, responsibilities may include:

Contribute to labeling submissions for US and EU, including QC, proofing, copy editing and formatting of documents

Ensure proper version control and document integrity of packaging component labeling, printed labeling artworks and other assigned labeling documents.

As requested, assist in maintaining repository of current labeling documents and with uploading of documents to electronic document management system.

Review product labeling galley proofs for the Physician’s Desk Reference, as appropriate.

As requested, participate in the development and maintenance of work practices, templates, and associated documents relating to the labeling function.



Essential Education, Qualifications, Skills and Experience

Bachelor’s Degree or equivalent experience

Experience in a proofreading capacity

Able to multi-task

Excellent planning and organizational skills

Excellent oral and written communication skills in English

Self-motivated and proactive worker

Proficiency in the use of Microsoft Word, Excel, Project, Adobe Acrobat and other software programs

Capable of working collaboratively with colleagues in all functions. Team player

Exercise good judgment and operate with large degree of independence regarding routine assignments

Cultural Awareness – able to work successfully in a multi-cultural environment



Desirable

Work experience in a biotech/pharmaceutical arena (preferably in labeling) is highly desirable.

Experience working in a GMP pharmaceutical environment preferred. 



Deadline for applications: 2014-08-12

More information: Per Hillertz, tel. 0733-434018.



Organization/Business description:
Dfind Science & Engineering är ett konsult- och rekryteringsföretag specialiserade på kompetenser inom naturvetenskap och teknik. Med engagemang och lyhördhet hjälper vi människor och företag att hitta lösningar för att utvecklas. Hos oss har du möjlighet att utveckla dina kunskaper och färdigheter genom uppdrag hos våra utvecklings- forsknings- och produktionsintensiva kunder i Norden.

Vi tycker att det är viktigt att all kompetens på arbetsmarknaden tillvaratas. Vi välkomnar alla sökande och eftersträvar mångfald. Dfind Science & Engineering ett auktoriserat bemanningsföretag via Almega och följer deras kollektivavtal.