Regulatory Operations Manager to AstraZeneca Gothenburg
Alten Sverige AB / Sjukhusteknikerjobb / Göteborg
2018-01-15
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hela Sverige ALTENs Pharmateam is searching for a Regulatory Operations Manager for a consultancy assignment at AstraZeneca in Gothenburg.
ABOUT ASTRAZENECA:
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
THE ARENA:
WOULD YOU LIKE THE OPPORTUNITY TO WORK IN A GLOBAL TEAM ENVIRONMENT? DO YOU HAVE EXPERIENCE OF WORKING WITH END-TO-END DOCUMENT AND SUBMISSION PUBLISHING? THEN THIS MIGHT BE THE RIGHT ROLE FOR YOU!
AT ASTRAZENECA WE TURN IDEAS INTO LIFE CHANGING MEDICINES. WORKING HERE MEANS BEING ENTREPRENEURIAL, THINKING BIG AND WORKING TOGETHER TO MAKE THE IMPOSSIBLE A REALITY. WE ARE CURRENTLY LOOKING FOR ONE CONSULTANT FOR THE ROLE AS REGULATORY OPERATIONS MANAGER (ROM) TO OUR SITE IN GOTHENBURG, SWEDEN.
THE POSITION IS A TEMPORARY ASSIGNMENT LASTING UNTIL 2018-08-31.
THE REGULATORY OPERATIONS MANAGER (ROM) IS AN EXPERT IN END-TO-END DOCUMENT AND SUBMISSION PUBLISHING. THE ROM IS ALSO AN EXPERT IN UNDERSTANDING HEALTH AUTHORITY REQUIREMENTS AS WELL AS THE REGULATORY REQUIREMENTS REGARDING TECHNICAL AND FORMATTING ASPECTS OF GLOBAL REGULATORY SUBMISSION PUBLISHING.
ESSENTIAL REQUIREMENTS:
• Ability to provide global expertise on requirements for electronic document management, submission compilation and publishing.
• Demonstrated ability to work collaboratively in a global team environment and to have good project management skills
• Demonstrates a broad working knowledge of process improvement methodologies, tools, techniques and their application.
• Demonstrate an understanding of the characteristics in building successful supplier relationships, monitors Service Level Agreements (SLAs) and manages routine quality, resource and performance issues to resolution.
• Demonstrated ability to work independently and to set and manage priorities, resources, performance targets and project initiatives in a global environment.
• Ability to assess data, documentation and processes for regulatory impact/compliance with relevant regulations and guidance and clearly communicate requirements to immediate stakeholders.
• Ability to use project management principles and techniques.
• Excellent English written and verbal communication skills.
DESIRABLE REQUIREMENTS:
• Experience from planning, preparation and delivery of regulatory submissions throughout the product's life cycle.
• Experience from analysing queries from the user community to identify improvement opportunities in Systems, Cue Cards, Training Materials and business processes.
• Experiences from providing support in assisting users with questions related to end-to-end document and submission publishing.
• Experience in pharmaceutical/medical industry and/or knowledge of the drug development process, product life-cycle and contents/formatting of regulatory submissions.
• Experience of system administration for validated applications within a regulated environment.
• Experience from electronic document managements systems.
• Good problem and conflict resolution skills.
ABOUT ALTEN:
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
rickard.westergren@alten.se.
We wish you a Merry Christmas and A Happy New Year!
Varaktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2018-01-15ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2018-01-26
Klicka på denna länk för att göra din ansökanKontaktHR-avdelningen, Alten
recruitment@alten.seFöretagAlten Sverige AB
AdressAlten Sverige AB
Theres Svenssonsgata 15
41755 Gothenburg
KontorsadressTheres Svenssonsgata 15, Göteborg
Jobbnummer 3902484
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