Posted to MedZilla on 2/19/2018

Takeda Pharmaceuticals

US-MA, Senior Business Analyst, Global Regulatory Affairs Systems 1702841-MZ


  • Identifies business problems and analyzes and documents business requirements.
  • Establishes scope and business priority-setting for change initiatives of small and medium size and complexity, and participates in system implementations.
  • Identifies and investigates operational needs and problems, and opportunities, contributing to the implementation of improvements within area of responsibility.
  • Working as part of a global project team, this position is responsible for providing cross functional, cross regional end user inputs to IT projects for Regulatory Affairs systems.
  • Provide business system analysis support for key projects and enhancements.
  • Work with key vendors providing IT solutions and/or support for Global Regulatory Affairs.
  • Have an understanding of current regulatory requirements.
  • Works under general direction within a clear framework of accountability. Exercises substantial personal responsibility and autonomy. Plans own work to meet given objectives and processes.
  • Provides business consulting support to customers.
  • Identifies issues and helps with resolution efforts. Escalates issues appropriately.
  • Proactively identifies and assists in prioritizing opportunities to streamline business and/or system processes.
  • Analyzes and documents business requirements for area of responsibility. Ensure documentation according to Takeda QMS standards, policies and procedures.
  • Provides delivery of small to medium-scale changes and delivery of IT projects.
  • Establishes and maintains relationships with key customers.
  • Provides input into project budgets.
  • Assists in monitoring and reporting on projects within own area.
  • Works closely with vendors to complete required tasks.

  • Bachelors Degree or high school degree and 5+ years of work experience in any business related field, with 3-5 years of relevant experience.
  • Experience supporting functional processes and technical design.
  • Knowledge of relevant systems solutions.
  • Excellent oral and written communications skills, business acumen with problem solving and analytical skills.
  • Ability to write and speak in the English language


  • Experience supporting Regulatory Affairs, document management (Documentum and CSC FirstDoc), registration tracking (LIQUENT InSight) and/or publishing (CSC eCTDXPress) applications strongly desired.
  • Experience supporting global business functions, supporting large, complex and/or global applications and implementing global and/or large applications strongly desired.
  • Experience with system validation processes strongly desired.
  • Experience with validated systems governed by the Food and Drug Administration (FDA) regulations and International Council for Harmonisation (ICH) strongly desired.
  • Previous experience with application outsourcing and/or vendor management strongly desired.
  • Previous experience in IT supporting R&D development areas such as Regulatory, Clinical Operations, Data Management, PV/Safety, etc. desired.
  • Overall understanding of the Pharmaceutical Development processes desired.
  • Experience with formal SDLC methodology desired.
  • Pharmaceutical industry and/or drug development business experience.
  • Familiarity with regulated systems general level of understanding of systems validation

Submit your resume and start a quality career with Takeda!
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