CMC Documentation Specialist
Modis Sweden AB / Biologjobb / Mölndal
2018-04-05
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hela Sverige Modis Life Science is looking for a CMC Documentation Specialist to AstraZeneca in Gothenburg!
The Consultant assignment will start 2018-05-07 and proceed until 2019-11-08.
Welcome with your application no later than April 11th!
CMC Documentation Specialist, Pharmaceutical Technology & Development
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. We are looking to recruit for an 18 month period.
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 Modis
We are constantly striving to support our customers and consultants to become successful. As a consultant, you are our top priority and when you need us, we will be there for you.
We will include you in our business and to our customers. You are our most important asset and for us to stay ahead you will take an active part in our business development and our offers to the market.
By becoming our colleague, your daily life as a consultant will be shifting with different assignments and projects in a variety of industries, systems and environments. Your experience will increase as well as your social and professional network. As a consultant, you are covered by collective agreements, insurance, occupational healthcare, healthcare and discounts on training cards. We believe in connecting people so having regularly social activities is key for us.
Modis delivers a wide range of services and competencies within IT, Engineering and Life Science. Our services are characterized by speed, simplicity and quality. Modis is represented in the United States, Canada, Europe with over 100 offices and with more than 35,000 colleagues on assignments each day.
Are you interested?
Then you should apply as soon as possible. The position is soon to be filled and therefore work with recruitment is being done on a continual basis.
If you have questions regarding the position please contact:
Anneli Bermbeck
anneli.bermbeck@modis.se 073 684 83 33
We look forward to your application!
Varaktighet, arbetstid
Heltid Visstid
Publiceringsdatum2018-04-05ErsättningFast lön
Så ansöker duSista dag att ansöka är 2018-04-12
Klicka på denna länk för att göra din ansökanKontaktAnneli Bermbeck
FöretagModis Sweden AB
AdressModis Sweden AB
Hamngatan 13
11146 Stockholm
KontorsadressHamngatan 13
Jobbnummer 4063819
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