CMC Documentation Specialist to AstraZeneca
Poolia Göteborg AB / Apotekarjobb / Göteborg
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hela Sverige Would you like the opportunity to work in a global team environment? Do you have knowledge of the drug development process, product life-cycle, and contents/formatting of regulatory submissions? If the answer is yes, then this could be a role for you! We are currently looking to hire a CMC Documentation Specialist for consulting assignment at AstraZeneca. The preferred start for the assignment is 2018-05-07 and will last until 2019-11-08. If this sounds interesting the next step is to apply now!
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.
A CMC Documentation Specialist opportunity is now available in the CMC Documentation Group.
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
About Poolia & AstraZeneca
Poolia 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.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. 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.
Varaktighet, arbetstid
Heltid Sex månader eller mera
Publiceringsdatum2018-04-13ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2018-04-26
Ange följande referens när du ansöker: 49986
Klicka på denna länk för att göra din ansökanFöretagPoolia Göteborg AB
AdressPoolia Göteborg AB
Kungsgatan 42
41115 Göteborg
KontorsadressKungsgatan 42
Jobbnummer 4082785
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