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About the profileAbout MIGxMIGx is a global consulting company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory aspects. We have been managing challenges and solving problems for our clients in the areas of compliance, business processes and many others.MIGx interdisciplinary teams from Switzerland, Spain and Georgia have been taking care of projects in the fields of M&A, Integration, Application, Data Platforms, Processes, IT management, Digital transformation, Managed services and compliance.Project DescriptionOur company is rapidly growing and now we are looking for a Business Analyst/Life Sciences Consultant with a Life Science / Pharma R&D focus to join our team of professionals. For this role you should have a minimum of 3 years of experience in a relevant business analyst, technical, scientific or SME role within the pharmaceutical or biotech industry.Join MIGx as a Business Analyst/Life Sciences Consultant and help shape the future of pharmaceutical R&D. Work with global teams to drive digital transformation and data excellence in life sciences.ResponsibilitiesWork closely with cross-functional teams to gather and analyze business requirementsCreate technical specifications and other documentationProduct Owner and/or Product Manager experience (PB mgt, definition of Features, US, etc.)Analyze and model complex process/data flows to support pharmaceutical R&D or CMC initiativesSupport system implementation, integration, data quality initiatives and validation effortsParticipate in requirement workshops and User Acceptance TestingUsing subject matter expertise to support and guide internal teamsAct as a trusted advisor to clients, offering insights on digital transformation in life sciencesParticipate in workshops, gap analyses, and process improvement initiatives.Requirements - Must haveExperience with drug development lifecycle, clinical trials, regulatory requirements, manufacturing (e.g., GxP, FDA, EMA)Subject matter expertise in an area of Pharmaceutical R&D or CMCExperience with data modeling, requirements engineering, and process mappingFamiliarity with Pharma R&D systems (e.g., CDMS, CTMS, PV, RIM, LIMS, ELN, or eTMF systems)Proficiency in data visualization tools like Power BI, Tableau, SpotfireRequirements - Nice to haveExperience with data lifecycle management, metadata strategy, and data stewardshipFamiliarity with any of biostatistics, bioinformatics, clinical data, research data, RWD or lab informaticsExperience of CMC processes (e.g. product stability validation, batch tracing) and systemsKnowledge of data standards (e.g., CDISC, HL7, IDMP) and data governanceProficiency in a programming language like R, SAS or PythonExperience with requirements management tools (e.g., Jama, DOORS) and Software Development Lifecycle instruments (e.g., Jira, Azure DevOps)Understanding of "Data as a Product" principles and data product ownershipExperience with Data Mesh, graph databases, and ontology development to support next-gen data architecturesExperience with Data Modeling: Relational, Dimensional, GraphExperience with data-focused solutions in the cloud e.g. Azure: Synapse, Databricks
