Regulatory Affairs System and Strategy Specialist Pharma
Posted on Oct 30, 2020 by RM IT Professional Resources AG
RA System and Strategy Specialist Pharma vacancy for a globally operating Basel based company in the pharma sector.
- 2+ years of work experience within the pharma sector or a related industry, preferably in regulatory environments
- Expertise with RA relevant computer programs and systems with proven ability to learn as well as train others on new systems
- Knowledge of international Health Authority submission formats as well as of the overall drug development process and related document requirements are desired
- Know-how of eCTD, IDMP, Publishing Standards and applicable related tools is a plus
- Familiarity with ticketing tools, validation tools and concepts of GxP Software Development, testing experience is an asset
- University degree in Computer Science, Life Science or a related relevant discipline, Master degree preferred
- Languages: English, fluent in written and spoken
- Providing first line system and end user support as well as incident management and service request management including assessing, resolving or escalating technical issues
- Coordinating with 2nd level support and addressing escalated system issues
- Formulating user manuals, working instructions and training materials while ensuring trainings are recorded and maintained in the quality system within the company
- Contributing to RA project initiatives involving migration, requirements gathering and analysis as well as deployment activities
- Validating and implementing system upgrades and functionality enhancements
- Mapping business models and existing systems as well as establishing scope and business priority for change initiatives by communicating with stakeholders
- Facilitating communication and collaboration between teams regarding RA owned applications including monitoring problems and summarising activities to report to the management
Does this Spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.
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As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.
Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
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