Regulatory Project Assistant at AstraZeneca Gothenburg
Poolia Väst AB / Administratörsjobb / Mölndal
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Do you have good administrator IT skills? Are you communicative and interactive? Are you able to start now?
As a Regulatory Project Assistant (RPA) you will act a as specialist providing regulatory specific administrative support to the GRET (Global Regulatory Execution Team) to ensure the delivery of business objectives.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
The consulting assignment will start as soon as possible and go on for one year.
Are you the one we and AstraZeneca are looking for? Apply now - the recruitment process is already ongoing!
Arbetsuppgifter
The arena
The Regulatory Project Management (RPM) group sits within the AZ Global Regulatory Affairs, Patient Safety and QA (GRAPSQA) organisation and is accountable for end to end regulatory project delivery, providing regulatory expertise, efficient project management and strong leadership in line with business priorities.
We now have the opportunity for one consultant to join our team in the role as Regulatory Project Assistant (RPA) within the RPM CVMD & NS team. The Regulatory Project Assistant (RPA) is a specialist providing regulatory specific administrative support to the GRET (Global Regulatory Execution Team) to ensure the delivery of business objectives. The role is on a temporary basis for one year and you will be located in Gothenburg.
Accountabilities/Responsibilities
• Ordering and processing requests for Certificates of Product Profile
• Requesting and handling legal documents
• Creating and handling Submission Lists
• Coordinating forecasts for registration samples
• Updating trackers and spreadsheets
• Creating and linking documents in the Submission Management Request Tool (SMRT)
• Creating, importing, and exporting documents into and out of FirstDoc (ANGEL)
• Managing Linguistic Review submissions
• Supporting Trial Master File (TMF) regulatory document filing and quality checking (QC)
• Handling of documents in Box
• Creating Opal Plans Missing Actuals Report
• Downloading Artworks from GAZELLE
• Handling translations
• Providing coaching, mentoring and knowledge sharing within the RPA skill group
• Contributing to process improvement
Utbildning/erfarenhet
Minimum requirements
• Relevant professional experience in administrative support skills
• Very experienced user of advanced computer systems, software or system tools, e.g. document management system and/or publication tools
• Experience of working in multi-disciplinary project teams in a global multi-cultural setting
• Very good written and verbal communication skills in English
• Communication and influencing skills
• Flexibility and adaptability
• Interpersonal and networking skills
• Team working skills
• Continuous Improvement and knowledge sharing focus
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 Life 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.
Vår kunds hemsida
https://www.astrazeneca.com/ Sluttext
Does the consulting assignment sound interesting for you? Please apply, with only your english CV, even if you do not meet all minimum requirements and key factor requirements. In this recruitment, we will prioritize your personal qualities - together with your true passion for AstraZeneca and their medical products.
Language
en-GB
Varaktighet, arbetstid
Heltid Visstid, mer än 6 månader
Publiceringsdatum2017-09-20ErsättningFast lön
Så ansöker duSista dag att ansöka är 2017-09-29
Ange följande referens när du ansöker: 47807
Klicka på denna länk för att göra din ansökanKontaktJenny Lundkvist
jenny.lundkvist@poolia.seFöretagPoolia Väst AB
AdressPoolia Väst AB
Kungsgatan 42
41115 Göteborg
KontorsadressKungsgatan 42
Jobbnummer 3707324
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