CMC Documentation Specialist at AstraZeneca
Dfind Science & Engineering AB / Apotekarjobb / Göteborg
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hela Sverige CMC Documentation Specialist at AstraZeneca
A CMC Documentation Specialist opportunity is now available in the CMC Documentation Group at AstraZeneca. This is a consultant assignment for a period of 18 month.
The arena
Pharmaceutical Technology & Development (PT&D) is accountable for delivering the design and innovative, efficient and robust processes for the manufacture of drug product and drug substance, the supply of product for toxicological and clinical trials and the generation of information and knowledge to ensure regulatory approval of our products. The delivery of the Chemistry Manufacturing and Controls (CMC) contribution of a submission for Clinical Trial and Marketing applications by CMC Documentation is a core accountability for PT&D.
The role
Typical Accountabilities:
• Be the expert and provide advice on CMC submission technical requirements to Project Teams, including internal and external partners, throughout the lifecycle of a product.
• Manage and build CMC regulatory submissions for clinical trial and marketing applications in accordance with current standards and processes using agreed upon tools.
• On behalf of PT&D, manage compliance in the AZ Regulatory Document Management system (ANGEL), including access to Quality information.
• Provide AZ Regulatory Document Management system functional training for PT&D authors to enable efficiently of the system.
• Collaborate with the CMC Documentation Leads on CMC regulatory contributions
• Contributing specialist CMC knowledge to cross functional submission delivery teams
• Partner with peers (local and globally) to facilitate the delivery of CMC components for regulatory submissions.
• Accountable for the technical quality and delivery of all CMC submissions.
Minimum experience - Education and Experience
• Preferably a University degree in a science related field.
• Experience in understanding CMC dossier structures and advanced knowledge of common file formats (eg, Word) and related publishing tools (eg, ISI Toolbox, Adobe Acrobat, eCTDXPress)
• Expertise in using Document Management Systems, e.g., advanced ANGEL knowledge in order to be able to support and train
• Good understanding of the pharmaceutical industry, drug development, regulatory requirements, other PT&D and AZ departments and how they contribute to business objectives and AZ processes.
• Knowledge of regulatory authority requirements on electronic submissions in several regions (eg, US, Europe, etc.).
• Expert skills in managing system functionality and liaison with IS/IT experts.
• Highly developed influencing skills and interactive communication when interacting with people at all levels and within teams.
• Demonstrated ability to set and manage priorities, resources, goals and project initiatives.
• Experience working in cross-functional, global project teams.
• Excellent communication skills preferably in Swedish and English
• Understand own role and how it inter-relates with others in global PT&D, Clinical, Operations and Regulatory Affairs that use ANGEL to support the objectives of the business
• Ability to work diligently towards timelines and AstraZeneca standards
• Trainer skills to successfully deliver functional ANGEL training
Preferred Background:
• Knowledge of the drug development process, product life-cycle, and contents/formatting of regulatory submissions
Business: Dfind Science & Engineering
City: Gothenburg
Deadline for applications: 2018-04-12. Selection is on-going and interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application at your earliest convenience!
For more information contact: Alma Zanqrelle
alma.zanqrelle@dfind.se Please keep in mind, e-mail applications will not be considered. Register your profile at Dfind Science & Engineering's webpage and send in your application there.
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 world's second largest company within recruiting and staffing.
Varaktighet, arbetstid
Heltid Visstid
Publiceringsdatum2018-04-05ErsättningFast lön
Så ansöker duSista dag att ansöka är 2018-04-16
Ange följande referens när du ansöker: 201138359
Klicka på denna länk för att göra din ansökanKontaktAlma Zanqrelle
FöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Södra Hamngatan 35
41110 GÖTEBORG
KontorsadressSödra Hamngatan 35, 41110 GÖTEBORG
Jobbnummer 4063970
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