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Healthcare company is looking for a Lead Business Analyst.
Multinational pharmaceutical and biopharmaceutical company that operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
Company is embarking on an exciting project to bring a digital pathology AI Imaging algorithm to clinical trials and to clinical care. This role will focus on taking the algorithm from R&D environment into a CAP CLIA lab for use in clinical trials.
Responsibilities:
- Document the Imaging workflow needed to enable data scientists to develop an AI algorithm
- Work to document the requirements for access, use, processing etc. to develop an AI algorithm
- Understanding requirements from the CAP CLIA vendor’s position
- Provide Imaging expertise alongside the rest of the team and help define the strategy and product to a possible Digital Diagnostic (Software as a Medical device class IIb/III)
- To author and review documentation to meet the requirements of the project
Requirements:
- 5+ years of experience as a Business Analyst
- Experience in authoring and reviewing documentation (including GxP)
- Experience in preparing and analyzing requirements specifications
- Understanding of image analysis, radiology and/or digital pathology device development experience in a regulated setting
- Experience with Jira stories (description, acceptance criteria, effort estimation and detailed subtasks)
- Knowledge of BDD scenarios, process flows, use case development, gap analysis
- Good communication skills and facilitation skills with the ability to work in a team
- Significant project delivery experience in an Imaging environment
- Science and/or Pharmacovigilance background
- B2+ level of English
Nice to have:
- Familiarity with business analysis professional best practices
- Influencing and Innovation skills
- Basic knowledge of Clouds
- Experience in manual testing or writing tests with testers
- Radiology and/or digital pathology background highly desirable
