senior business analyst for a healthcare company

Business Analysis, Medical Imaging Systems, Medicine, Pharmacoviligance

Georgia

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Senior Business Analyst for a Healthcare Company

Hidden job

Currently, we are looking for a remote Senior Business Analyst to join our team.

The customer is a multinational pharmaceutical and biopharmaceutical company that operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

We are 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

3+ 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