Senior Solutions Engineer, Global Development Operations Systems

  • Company: Takeda
  • Location: Cambridge, Massachusetts
  • Posted: October 26, 2017
  • Reference ID: 1702832

OBJECTIVE:

  • Leads analysis, defines and establishes design of all technical aspects or provides technical expertise for IT solutions on complex IT systems projects within area of expertise.
  • Maintains and uses knowledge of solutions and IT landscape to explore and identify possible solutions related to defined technical problems, and finds opportunities to improve business solutions support.
  • Maintains and partly creates elements of large/complex solutions.




ACCOUNTABILITIES:

  • Reports to Global Development Operations Systems Head.
  • Support the development of systems roadmaps with business partners for Global Development Operations.
  • Acts as IT system technical expert for identified systems/applications.
  • Acts as primary contact with applicable software vendors and knowledge expert regarding vendor application roadmap and support escalation processes.
  • Provides technical expertise/knowledge in support of key projects.
  • Primary IT interface with key vendors providing IT solutions and/or support for Global Development Operations.
  • Has an understanding of current & future regulatory requirements and industry trends and assess the impact on business process and systems.






Qualifications:


EDUCATION, EXPERIENCE AND SKILLS:

Required
  • Experience with formal SDLC methodology.
  • Excellent ability to work independently but seek management support and guidance as needed.
  • Excellent skills in building multi-cultural relationships via strong collaboration and communication skills.


Preferred
  • Technical knowledge/expertize of streamlining Clinical Development applications' data flow in light of business process changes strongly desired
  • T echnical knowledge/expertise of applications such as CTMS, eTMF strongly desired.
  • Tecnical knowledge/expertize of the newest technology innovation such as Machine Learning for Clinical Development desired
  • Experience supporting Development Operations 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 and 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 support of R&D development such as Clinical Operations, Regulatory, Data Management, PV/Safety, etc. desired.
  • Overall understanding of the Pharmaceutical Development processes desired

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