About
MIGx 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. Our 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.
Responsibilities
•Work closely with cross-functional teams to gather and analyze business requirements
•Create technical specifications and other documentation
•Product 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 initiatives
•Support system implementation, integration, data quality initiatives and validation efforts
•Participate in requirement workshops and User Acceptance Testing
•Use subject matter expertise to support and guide internal teams
•Act as a trusted advisor to clients, offering insights on digital transformation in life sciences
•Participate in workshops, gap analyses, and process improvement initiatives
Requirements
•Experience 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 CMC
•Experience with data modeling, requirements engineering, and process mapping
•Familiarity 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, Spotfire
Will be a plus
•Experience with data lifecycle management, metadata strategy, and data stewardship
•Familiarity with any of biostatistics, bioinformatics, clinical data, research data, RWD or lab informatics
•Experience of CMC processes (e.g. product stability validation, batch tracing) and systems
•Knowledge of data standards (e.g., CDISC, HL7, IDMP) and data governance
•Proficiency in a programming language like R, SAS or Python
•Experience 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 ownership
•Experience with Data Mesh, graph databases, and ontology development to support next-gen data architectures
•Experience with Data Modeling: Relational, Dimensional, Graph
•Experience with data-focused solutions in the cloud e.g. Azure: Synapse, Databricks
Conditions
No conditions are specified in the posting.
