The Senior Business Solutions Expert will provide leadership to the analysis of complex business problems and manages business requirements within Global Drug Safety and Pharmacovigilance. Leads development of scope and business priority-setting for change initiatives of large size and complex system implementations. Proactively identifies technology solutions and influences business objectives, taking into account the implications of change on the organization and all stakeholders.
The role is based in Cambridge and reports to the Global Head of Pharmacovigilance Systems.
The Senior Business Solutions Expert will:
Manages requirements gathering, prioritization and negotiation with business stakeholders in order to ensure the total solution delivered meets or exceeds expectations.
Maintains, influences and impacts business process design; validates and interprets business needs by conducting feasibility studies and drafting business cases.
Solves or leads others to solve 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, translates operational needs, problems and opportunities into business solutions.
Manages project or matrix team to deliver 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 large area of work, including technical, financial and quality aspects.
Ensures documentation according to Takeda QMS standards, policies and procedures.
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.
Establishes and builds relationships with relevant colleagues from Global Functions within the Global IS/IT Organization (PMO s, EADS and ITIO) and is person to go to for leading change in analyzing and guiding on solutions within ongoing processes
EDUCATION, EXPERIENCE AND SKILLS:
Experience working in Life Sciences, Clinical or Pharmaceutical industries
Strong knowledge of processes and applications related to Drug Safety & Pharmacovigilance (e.g. Oracle Argus Safety, Empirica, ARISg, Axway and etc.)
Knowledge of procedures and best practices related to FDA, EMA, GxP,
CFR 21 Part 11, Computer System Validation)
Knowledge of compliance international Regulations and ICH environment foundations
Cloud based software applications, packaged application, platform implementations, or custom development experience
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We are an equal opportunity employer.
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