Posted to MedZilla HealthCare on 10/20/2018


Takeda Pharmaceuticals

US-MA, Business Solutions Expert, Global Development Operations Systems R0004107-MZ


 
 

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us a Business Solutions Expert in our Cambridge, MA office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Business Solutions Expert working in the Global Development Operations Systems team, a typical day will include:

OBJECTIVES:

  • Leads the analysis of complex business problems and manages business requirements within area of responsibilities.
  • Leads development of scope definition and business priority-setting.
  • Proactively identifies technology solutions to meet business objectives, taking into account the implications of change on the organization and all stakeholders.

ACCOUNTABILITIES:

  • Reports to Global Development Operations Systems Head.
  • Support the development of systems roadmaps with business partners for Global Development Operations.
  • Act as IT system owner for identified systems/applications re Clinical Trial Management System.
  • Provide business analysis and project management support for key projects and enhancements
  • IT interface with key vendors providing IT solutions and/or support for Global Development Operations.
  • Provide oversight and instruction to one or more technical support teams for systems under his/her ownership
  • Act as a liaison and advocate for Global Development Operations clients with other parts of the IT organization.
  • Assesses the impact on business processes and systems and is taking current and proposed regulatory requirements and industry trends into consideration
  • Responsible for tracking licenses for applications and processing annual renewals working with Procurement and Legal teams when necessary
  • Works with various IT teams to support IT-driven changes and initiatives impacting supported systems and/or business partners
  • Manages requirements gathering, prioritization and negotiation with business stakeholders in order to ensure the total solution delivered meets or exceeds expectations.
  • Maintains and influences business process design; validates and interprets business needs by conducting feasibility studies and drafting business cases.
  • Solves unique and complex problems with a broad impact on the business and interprets ways of prioritizing opportunities to streamline business and/or system processes.
  • Uses knowledge of business operations, investigates and identifies operational needs, problems and opportunities and uses Business Process Mapping to phrase and manage requirements or organizational improvements.
  • Provides leadership to project team to deliver mid-size and moderate complex system implementations, within cross functional projects that allow the business to reach its strategic objectives in a cost effective way. Makes decisions that impact, the work of employing organizations, achievement of organizational objectives or/and financial performance.
  • Has authority and responsibility for a significant area of work, including technical, financial and quality aspects and may represent the organization.
  • Ensures documentation according to Takeda Quality Management System (QMS), Software Development Life Cycle and Project Life Cycle standards.
  • Ensures delivered solutions are compliant with associated federal regulations (SOX, OFCCP, labor laws, GMP, GxP, GCP, etc.).
  • Is a subject matter expert in the business area of expertise and actively shares emerging industry standards/trends with customers and peers.
  • Establish relationships with relevant colleagues from Global Functions within the Global IS/IT Organization (PMO s, EADS and ITIO) and leads change in analyzing and guiding on solutions within ongoing processes.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Required:

  • Bachelor Degree or equivalent5 years or more of relevant experience.
  • Ability to write, speak and lead in the English language.
  • Excellent oral and written communications skills, business acumen with problem solving and analytical skills.
  • Professional in depth knowledge of business processes in pharmaceutical industry within functional area.
  • Experience with formal SDLC methodology.
  • Knowledge of business and system solutions and experience with implementing applications.
  • Experience in Business Analysis and Project Management.
  • Experience in Stakeholder relationship management.
  • Experience in communicating complex information in a clear and engaging manner, adjust form and meetings to this and builds collaborative network of relationships in the business area and outside.
  • Experience in presenting on conferences and business meetings.
  • 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:

  • Master Degree.
  • Experience supporting Development Operations and/or applications such as SAS, eTMF, Clinical Trial Data Transparency, 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.
  • Strong cross-team/cross-initiative negotiation skills desired
  • Previous experience in IT supporting R&D development areas such as Clinical Operations, Regulatory, Data Management, PV/Safety, etc. desired.
  • Overall understanding of the Pharmaceutical Development processes desired.
  • Experience in managing people.
  • Experience with regulated systems good level of understanding of system validation.

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