Analyst, IT Project Management, Cyber & Ops | Onsite San Diego HQ

Neurocrine Biosciences • San Diego, CA

1d • Onsite

About The Position

Supports cross-functional teams to address business systems needs/issues. Provides analysis of complex business problems to be solved with automated systems. Provides technical assistance in identifying and evaluating systems and procedures that are cost-effective and meet user requirements. Executes unit integration and acceptance testing; and may create specifications for systems to meet business requirements. Provides consultation to users in the area of automated systems.

Requirements

• 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
• Master’s degree in computer science or IT preferred and some related experience noted above
• PMP certification or working towards certification a plus
• Good knowledge of Microsoft applications / data base and programming technologies
• Good knowledge of with web technologies such as HTML, XML, or latest mark up language, Visual Basic / Java based or similar language and Internet Database Programming
• Knowledge of validated applications for regulatory purposes in a biotech/pharmaceutical company
• 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
• Recent experience supporting implementation of business applications, including Microsoft applications, preferred utilizing some or all the following technologies: 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.
• 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.
• Has experience in specific functional discipline while working to acquire higher-level knowledge and skills
• Comfortable with tools and processes that support work conducted by functional area
• Good project management skills with ability to meet deadlines.
• Ability to collaborate with a cross-functional business and technical project team.
• Excellent verbal, written, and interpersonal communication skills, including the ability to work collaboratively with all employee levels as well as external contacts (vendors).
• Excellent decision-making, conflict-resolution and influencing skills appropriate for a developing professional.

Responsibilities

• Participates on project teams in a supporting capacity for application implementation, administration, and support
• Reviews and assists in the development of processes required for the successful implementation of key software systems
• Provides support for the management of data from multiple sources and databases for submission to regulatory agencies
• Interacts with Clinical and Regulatory departments on issues relating to electronic submissions
• Supports evaluation and implementation of technologies that may improve the overall quality of systems across departments
• Consults with department representatives to determine requirements for data access, reports, and interfaces
• May interact with department managers, typically works with main system users to assess implementation of data management/interface tools, including regulatory and validation requirements for all Clinical/Regulatory data management projects
• Other duties as assigned

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees