CMC Documentation Specialist to AstraZeneca in Gothenburg
Personality / Commitment
ALTEN Pharma Gothenburg is searching for a CMC Documentation Specialist in Pharmaceutical Technology & Development for a consultancy assignments at AstraZeneca.
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.
Job / Skills
- 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
- Knowledge of the drug development process, product life-cycle, and contents/formatting of regulatory submissions.
For over 20 years, ALTEN has developed its business by keeping to the core values that have built up the company's success. Every year, hundreds of ALTEN consultants have been given the opportunity to embark on challenging technical projects for our customers. ALTEN has a tradition of developing products in many areas, and history in Sweden is based primarily on skills in mechanics, software and electronics. Thanks to a successful concept in which we utilize the expertise of experienced consultants and develop young abilities towards a successful career, we have gained ground in many industries. Our Pharma initiative is based on the same successful concept with the same strong structure, but in a new exciting industry and a new field of expertise that includes knowledge in chemistry, biotechnology and biomedicine.
As an employee at ALTEN, we offer you a competitive salary based on your performance and work experience. You also have the opportunity to influence your assignments, different benefits and your overall working environment as well as choose your career path. We offer a wide range of internal trainings and an opportunity to plan for an international career. It is our conviction that genuine commitment is created through choice and the ability to influence your own personal development - our business model provides that opportunity. This freedom of choice enables us to offer our clients the most committed consultants, regardless of assignments. At ALTEN, we believe in growing together!
For questions about the position, please contact Rickard Westergren, Business Manager Pharma, at firstname.lastname@example.org.
Ansökningstiden : 25/04/2018
Kontakt : Antonia Reimers
Region : Sweden - Västra Götaland - Gothenburg