IT BA/PM (Compliance)

A Biosciences company based in San Diego is seeking a technical business analyst/project manager to join their team in support of their Compliance, Clinical and R&D technical implementations. They will support cross-functional teams to address business systems needs/issues. Provide analysis of complex business problems to be solved with automated systems. Provide technical assistance in identifying and evaluating systems and procedures that are cost-effective and meet user requirements. Execute unit integration and acceptance testing; and may create specifications for systems to meet business requirements. Provide consultation to users in the area of automated systems. They will interact with department managers, typically supporting main system users to assess implementation of data management/interface tools, including regulatory and validation requirements for all Clinical/Regulatory data management projects.

BS/BA degree in computer science, IT, or similar Field and 2+ years of IT experience; working in a pharmaceutical company with exposure to FDA regulations preferred OR Master's degree in computer science or IT preferred and some related experience noted above 2+ years of experience as a technical BA or project manager Experience directly supporting or interfacing with Compliance and Regulatory teams Knowledge of Quality and Compliance Platforms and Learning Management Tools (Agiloft, ComplianceWire, Veeva, Docusign, DotCompliance) Strong experience gathering technical requirements from business stakeholders and acting as a liaison to technical resources Experience with project management tools for documentation and reporting (ServiceNow, Smartsheet) Familiarity with web application technology, electronic document management systems, electronic publishing systems for regulatory filings, and exposure in database technologies and data warehousing/data mining Previous experience supporting technical implementations of business applications, with experience utilizing some or all of the following technologies preferred: MS SQL Server, Oracle, JAVA, Visual Basic, MS Access, MS Project, IIS, Internet Explorer, and Advanced Web technologies such as HTML, XML, SGML, Dynamic HTML, JavaScript, VBScript, and Internet Database Programming

Nice to Have Skills & Experience

PMP certification or working towards certification a plus Some experience with web application technology, electronic document management systems, electronic publishing systems for regulatory filings, and exposure in database technologies and data warehousing/data mining a plus Experience supporting validated applications for regulatory purposes in a biotech/pharmaceutical company preferred. Some experience with web application technology, electronic document management systems, electronic publishing systems for regulatory filings, and exposure in database technologies and data warehousing/data mining a plus. Knowledge of validated applications for regulatory purposes in a biotech/pharmaceutical company

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.