Beschreibung
Business AnalystenID
7586
Einsatzort
0 Basel, außerhalb Deutschland
Branche
IT
Job-Typ
freie Mitarbeit
Datum Beginn
asap
Dauer
3 Monate
Beschreibung
• You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
You have a Bachelor’s degree in Computer Science, Life Sciences or similar with 6-9 years of business analysis experience in multiple areas of business domain and technology or related field experience with Health Authority / Regulatory Authority. You bring the following qualifications:
o Proficient knowledge of pharmaceutical Regulatory and Clinical processes, including knowledge and appreciation of scientific Regulatory affairs, ethical and compliance principles
o 5+ years of experience in the area of Regulatory Affairs and Clinical Development including the associated application landscape, with good knowledge of Regulatory industry standards desired
o Strong systems, user and functional requirements analysis and technical skills and proven skills in document authoring under Computer Systems Validation processes, (e.g. User Requirements Specification, Functional Specifications)
o Formal training and proficiency in software development methodologies and computer systems validation in regulated industries (biotech/pharma), and formal process training (e.g. Six Sigma, IIBA Certification) would be a plus
o Excellent presentation, meeting facilitation and communications skills (written and verbal in English, other languages are plus) and ability to work outside the standard office hours and according to different time zones as required, as well as to travel as required up to 20% of the time
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