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Jobs or company...

IT BA/BSA w/ GxP Regulations & Pharma/Life Science BG

Salary undisclosed
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This is a 100% remote job!!!

Job Description:

This position is responsible for bridging the gap between business needs and technical solutions and plays a pivotal role in ensuring that the solutions developed and implemented by IT align with our business strategies, objectives and processes. The position requires people with a blend of technical, analytical and interpersonal skills and how to apply these in the Pharmaceutical Industry. They will need to understand how to work with both GxP and non-GxP systems and a good understanding of the Clinical (Drug) Development Lifecycle.

The Business Analyst will be involved throughout the project lifecycle from initial concept through to delivery and post implementation support. They will be responsible for facilitating communication between stakeholders and IT Professionals, ensuring that the solutions developed address business problems and add value. They will be directly responsible for requirements gathering and analysis, modelling business and IT processes, managing project scopes, solutions design, in scope testing and ongoing user and system support.

Required Technical Knowledge/Experience/Skills:

  • Strong understanding of agile concepts and certification in agile methodology
  • Strong understanding of modern data systems and tools including data platforms, data warehouses, data lakes, data ingestion, distribution pipelines, and data analytics/visualization how to apply this knowledge to clinical and real-world data.
  • Strong Pharma/Life Sciences experience with an in-depth understanding of Clinical Development and Operations processes
  • Strong understanding and working knowledge of:
  • GxP Regulations (FDA, EMA, ICH), including FDA 21 CFR Part 11, ICH E6(R2)
  • Clinical Trial Data (STDM, ADaM, DTD, eCTD/XML)
  • Nonclinical Study Data (SEND)
  • Safety Data (ISO/HL7 27953: E2B(r2), E2B(r3); ICSR, PADER, PSUR, DSUR)
  • Experience working in a Computer System Validation (CSV) process and SDLC process.
  • Understanding and experience with Pharma related Technology Solutions/Platforms, including but not limited to:
  • PV Safety Databases/Technologies, EDC Platforms, IRT Platforms, Document Management Technologies e.g. Veeva, CTMS Technologies, ePRO, etc.
  • Strong understanding and experience designing solutions and working in and Azure and AWS Cloud Environments
  • Understanding of software development processes and methodologies (e.g., Agile, Scrum, Waterfall, SDLC).
  • Certified and experienced in working within an agile framework e.g. SaFe and as part of an agile team.
  • Able to work within Jira and is proficient in creating and managing Epics, User Stories and Tasks.
  • Able to analyze complex data to identify trends, patterns, and insights utilizing modern IT tooling.
  • Any relevant certifications (e.g., CBAP, PMI-PBA) or formal training in business analysis and solution development
  • Proficiency in using analytical tools and software for data analysis.
  • Ability to troubleshoot issues and implement effective resolutions.
  • Understanding of technical IT issues to organize discussions with internal and external technical specialists. Must be able to ensure best practices are used for each type of technology infrastructure: client/server, virtual environments (private, AWS, Azure), single or multi-tenant web-based Software as a Service (SaaS) solution.

Required Work Experience:

  • Advanced degree in computer science, technology, engineering, or related disciplines required.
  • 7+ years pharmaceutical/biotech company or consulting experience required.
  • Experience in clinical development.
  • Experience supporting heavily outsourced partner/vendor organizations including CROs/FSPs.
  • Experience working with and implementing data platforms and services.
  • Experience selecting, designing and implementing IT Applications
  • Experience working in both custom developed cloud-based solutions and as a Service solutions e.g. IaaS, SaaS, PaaS etc.
  • Experience defining data processes & standards and/or data integration mechanisms.
  • Experience leading regulated systems in a GxP regulated industry; Computer Software Validation (CSV), and IT SDLC
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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