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.
EDUCATION, EXPERIENCE AND SKILLS:
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!
We are an equal opportunity employer.
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