Business System Analyst - Clinical & Quality Systems

Location: 

Basel Area-Allschwil, BL, CH

 

 

About Idorsia Pharmaceuticals Ltd

Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.

In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical company, with a strong scientific core.

Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 600 highly qualified specialists dedicated to realizing our ambitious targets.

 

Job Responsibilities

 

The Business Systems Analyst is responsible for the management and support of Clinical & Quality Systems. This includes user support, as well as the implementation, integration, testing and management of the system releases, with a clear understanding of the pharmaceutical regulations within GxP environments.

The focus of this position is on electronic Document Management and Quality Management based on Veeva Vault.

 

  • Assessment of user needs through close cooperation with business functions to provide support and proactive service, including analysis of opportunities in accordance to the IT strategy and architecture
  • Focal point to communicate system related problems, in collaboration with the IT teams and the software vendor on changes, fixes, and updates
  • Ongoing troubleshooting, user support, and maintenance of systems and ensure customer satisfaction
  • Support for system release process including vendor management, coordination of validation activities with development and execution of testing, and end user communication
  • Development of training documentation and eLearning modules, and coordination or provision of end user training
  • Creation of system related QS documentation (SOPs, WISs, etc.) in compliance with relevant policies and standards
  • Guarantee compliance to CSV requirements, IT Policies, and standards
  • Configuration of new functionalities based on user requirements
  • Good understanding of business requirements and technology to support business objectives
  • Project management for selected business initiatives

 

 

Candidate’s Requirements

 

  • University degree in science, computer science, management information systems, or related field
  • Minimum five years of professional experience, preferably minimum three years in the pharmaceutical industry
  • Three or more years of experience in business area in support and managing relevant IT systems, e.g. electronic Document Management System (EDMS), Quality Management System (QMS), electronic Trial Master File Systems (eTMF), Clinical Trial Management System (CTMS), Electronic Data Capture (EDC)
  • Experience in drug development and clinical operations
  • Experience in development of training documentation and eLearning Modules and providing end user training
  • Strong knowledge in system management and administration, Veeva Vault end user or administrator experience is beneficial
  • Experience with managing software as a service (SaaS)
  • Strong knowledge of Computer System Validation and Code of Federal Regulations CFR 21 Part 11 and required documentation
  • Good understanding of GAMP5 software development and ITIL framework, certification is an asset
  • Very good knowledge of regulated environments (GxP, preferably GLP or GMP)
  • Experience with QMS processes (e.g. CAPA management, deviation management, change management) is beneficial
  • Strong communication skills, able to understand problems and present solutions towards business partners
  • Good analytical skills, and ability to understand business requirements, and transform into IT solutions
  • Independent, and hands-on working style, team player, highly self-motivated, autonomous, proactive and change oriented
  • Fluent in English (written and spoken), French and/or German is a plus

 

 

 

What Idorsia offers

 

  • Exciting opportunities  for development and professional growth within our dynamic organization
  • A collaborative and solution oriented enviroment where you can make a difference
  • An innovative and open culture in a truly multicultural environment
  • A competitive salary and generous social benefits

 

Work  Location: Allschwil

Country: Switzerland

Business Unit: Global Information Services

Schedule: Fulltime

Job Type: Permanent

Job ID: 1091

 

If you are interested, please click on apply now.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.

Please note Idorsia operates a strictly-controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.

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