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:
- 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.
- 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:
- 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.
- 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.