Regulatory Information Manager to AstraZeneca Gothenburg
Alten Sverige AB / Sjukhusteknikerjobb / Göteborg
Observera att sista ansökningsdag har passerat.
Visa alla sjukhusteknikerjobb i Göteborg,
Mölndal,
Partille,
Kungälv,
Lerum eller i
hela Sverige Visa alla jobb hos Alten Sverige AB i Göteborg,
Härryda,
Trollhättan,
Uddevalla,
Grästorp eller i
hela Sverige ALTENs Pharmateam is looking for 3 consultants in the position as Regulatory Information Managers to 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 Regulatory Information? Are you up for a new challenge in the ever-changing environment called RIMs?
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 now looking for 3 consultants for the role as Regulatory Information Manager, to join our team for a 12 month assignment.
TASKS AND RESPONSIBILITIES / THE ROLE:
AS REGULATORY INFORMATION MANAGER YOU WILL BE AN EXPERT IN END-TO-END TRACKING AND DOCUMENTATION, WHICH INCLUDES SET-UP, FOLLOW UP AND DOCUMENTATION OF REGULATORY SUBMISSIONS AND APPROVAL INFORMATION. AS A REGULATORY INFORMATION MANAGER, YOU WILL ALSO BE AN EXPERT IN UNDERSTANDING HEALTH AUTHORITY LEGISLATION INTERPRETATION AS WELL AS THE REGULATORY REQUIREMENTS WITH REGARD TO LICENSES AND CLINICAL TRIALS ASPECTS OF TRACKING AND LIFE-CYCLE MANAGEMENT.
TO BE SUCCESSFUL IN THIS ROLE YOU HAVE TO SHOW A DEMONSTRATED ABILITY TO WORK COLLABORATIVELY IN A GLOBAL TEAM ENVIRONMENT AND HAVE GOOD PROJECT MANAGEMENT SKILLS. YOU NEED THE ABILITY TO WORK INDEPENDENTLY AND TO SET AND MANAGE PRIORITIES, RESOURCES, PERFORMANCE TARGETS AND PROJECT INITIATIVES IN A GLOBAL ENVIRONMENT. IT IS IMPORTANT THAT YOU CAN 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.
ESSENTIAL REQUIREMENTS:
• Minimum 1 year hands-on experience with tracking of regulatory information.
• University degree or equivalent experience in life sciences or technical field.
• Ability to provide global expertise on requirements for tracking of regulatory submissions and approvals.
• 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.
• Experience from planning of large and complex business activities.
• Demonstrates a broad working knowledge of process improvement methodologies, tools, techniques and their application.
• Excellent English written and verbal communication skills.
DESIRABLE REQUIREMENTS:
IF YOU HAVE PREVIOUS EXPERIENCE OF SYSTEM ADMINISTRATION FOR VALIDATED APPLICATIONS WITHIN A REGULATED ENVIRONMENT THIS WOULD BE AN ADVANTAGE AS WELL AS KNOWLEDGE OF ASTRAZENECA SUBMISSION, PUBLISHING, APPROVAL PROCESSES, TOOLS AND STANDARDS. PREVIOUS EXPERIENCE IN USING ANGEL APPLICATIONS IS ALSO QUALIFYING. THE SUCCESSFUL CANDIDATE HAVE GOOD PROBLEM AND CONFLICT RESOLUTION SKILLS AND THE ABILITY TO SEE CHANGES AS AN OPPORTUNITY TO IMPROVE PERFORMANCE AND ADD VALUE TO THE BUSINESS.
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 (between December the 22nd and the 8th of January we will have limited opportunity to make selection and answer questions about the assignment due to the coming Christmas holiday).
Varaktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2017-12-21ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2018-01-19
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 3867820
Observera att sista ansökningsdag har passerat.