Regulatory Project Assistant at AstraZeneca
Dfind Science & Engineering AB / Apotekarjobb / Göteborg
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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 this 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
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
Business: Dfind Science & Engineering
City: Gothenburg
Deadline for applications: 2017-09-30. Selection is done continuously, so please send in your application as soon as possible.
More information: Eleonor Ehrman 0733-434109 or Alma Zanqrelle
alma.zanqrelle@dfind.se [ mailto:
alma.zanqrelle@dfind.se ]
Organization/Business description:
Dfind Science & Engineering is a recruitment and consulting company within science and engineering. All our consultant managers and recruitment consultants have an education and work experience within the respective field. In combination with extensive knowledge of staff issues and solid experience of recruitment, this means that we understand our clients' need for both flexibility and the right skills.
Dfind Science & Engineering is since 2016 part of Randstad Group. With over 600 000 employees in over 40 countries Randstad is the work second largest company within recruiting and staffing.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2017-09-20ErsättningFast lön
Så ansöker duSista dag att ansöka är 2017-09-30
Ange följande referens när du ansöker: 201082318
Klicka på denna länk för att göra din ansökanKontaktEleonor Ehrman
FöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Östra Hamngatan 23
41110 GÖTEBORG
KontorsadressÖstra Hamngatan 23, 41110 GÖTEBORG
Jobbnummer 3707639
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