Job Description
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.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Required Skills & Experience
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.