Regulatory Affairs Assistant – Proofreader for AstraZeneca

Presentation

For AstraZeneca we are now looking for a regulatory affairs assistent or proofreader for a consultant assignment. The assignment will start as sson as possible and go on for 6 month with possibilities for extension.

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, primarily in a proofreading capacity. Depending on ability, the candidate may also provide other operational support to ensure labeling document integrity and delivery.

Interviews and selections are held continously so please apply today!

Arbetsuppgifter

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 and printed labeling artworks
- 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
- Participate in the development and maintenance of work practices, templates, and associated documents relating to the labeling function

Utbildning/erfarenhet

We prefferably have a Bachelor’s Degree or equivalent experience and experience in a proofreading capacity. You are able to multi-task, have excellent planning and organizational skills as well as oral and written communication skills in English. You are self-motivated and proactive worker, proficiency in the use of Microsoft Word, Excel, Project, Adobe Acrobat and other software programs. You are capable of working collaboratively with colleagues in all functions. You exercise good judgment and operate with large degree of independence regarding routine assignments and have cultural awareness and is able to work successfully in a multi-cultural environment.

Work experience in a biotech/pharmaceutical arena (preferably in labeling) is highly desirable and experience working in a GMP pharmaceutical environment preferred.

Förmåner

We take good care of our consultants and we offer social activities, as well as help in planning your future career. Your consultant manager is well experienced from your field, and knows how to get the most out of your assignment.

As a Poolia employee, you are included in the requirements concerning agreements on terms of employment by Unionen. Moreover, you get a grant for working out at your choice of place. You are also covered by a health insurance.

Företagsbeskrivning

Poolia Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you.

Working as a consultant suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you’re looking for a world of exciting assignments and new contacts, you’ll like being a consultant.

Sluttext

Please apply by registering your CV here on our website. Click on the "Ansök" button to the right of this advertisement. It is our recommendation that you register as much information as possible and that you attach a complete CV-document. Please check that your correct e-mail adress is registered.

Poolia is a registered staffing agency, meaning that we comply with the requirements set by Bemanningsföretagen - the Swedish Association of Staffing Agencies.