Regulatory Project Assistant at AstraZeneca
S&C Bemanning Göteborg AB / Administratörsjobb / Göteborg
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Söder & Co är ett auktoriserat rekryterings- och bemanningsföretag. Vi har lång erfarenhet från branschen och vet hur viktigt det är med stark lokal förankring. Våra samarbeten bygger på relationer grundade på långsiktighet, engagemang, enkelhet och förtroende.
Det går bra för Söder & Co och en kul grej när det går bra är att man behöver bli fler. På Söder & Co är vi alltid intresserade av att knyta till oss rätt personer. För hos oss är det människorna som gör skillnad. Vi erbjuder dig marknadsmässig lön, tjänstepension enligt vårt kollektivavtal med unionen, friskvårdserbjudande, roliga medarbetaraktiviteter och personligt engagemang från din närmsta chef. Vår framgång bygger på din framgång. Välkommen till oss!
About the company
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.
Job description
The position as Regulatory Project Assistant is as a consultant. As a consultant, you are employed in Söder & Co. The assignment start immediately and is expected to last one year, with possible extension.
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.
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
Your profile
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
The position will be filled immediately. Interviews will be held continuously. If you find the role interesting, please apply through
www.soderco.se If you have any questions regarding this position please contact Lina Friberg or Niklas Ekeblad.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2017-09-20ErsättningFast lön
Så ansöker duSista dag att ansöka är 2017-09-29
Ange följande referens när du ansöker: 2694
Klicka på denna länk för att göra din ansökanKontaktLina Friberg 0760-502057
FöretagS&C Bemanning Göteborg AB
AdressS&C Bemanning Göteborg AB
Johan På Gårdas gata 5A
41250 Göteborg
KontorsadressJohan På Gårdas gata 5A
Jobbnummer 3708680
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