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Required: 10 years related experience that includes increasing levels of responsibility in gathering and defining requirements, analyzing/mapping business processes, supporting the design, development, implementation, and maintenance of solutions, services, products, and applications Required: 10 years experience required working with Trackwise, SAP Quality, Neptune or other QMS or Regulatory applications. Preferred: Experience working in other ERPs, RIM, MES systems etc. Skills and Requirements: Active and successful team lead/participant capable of motivating others within a non-direct reporting structure to execute change. Outstanding analytical skills and proven track record of utilizing team based approach to quickly and accurately resolve system/solution issues. Strong knowledge of business information technology best practices. Strong business analysis, and project management skills. Strong communication and writing skills on a business and technical level. Demonstrated skills in solution development and implementation from a business owner perspective. Strong skills in documentation for business and technology user audiences. Strong technical background and ability to effectively balance multiple priorities. Strong understanding of system development, IT and business process and their inter-relationship. Understanding of the Standards Development Life Cycle AND Software Development Life Cycle desired. Demonstrated collaborative and consensus building strengths. Proven creative problem solver with ability to work effectively in a hyper-changing environment.