Principal IT Project Manager, R&D

Who We Are:

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs, but few options.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington’s disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:

Leads cross-functional teams to address scientific business systems needs/issues for the Research and Early Development teams. Plans and directs the analysis of complex business problems to be solved with automated systems. Provides technical leadership in identifying, recommending and evaluating systems and procedures that are cost-effective and meet user requirements. Plans and leads 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.

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Your contributions:

• Lead project teams in the capacity of supporting application implementation, administration, and support

• Partners with department leadership to ensure successful implementation of data management/interface tools and systems. This may include both regulatory and validation requirements for GxP data management projects

• May provide technical support for the management of data from multiple sources and databases for the eventual submission to multiple regulatory agencies

• Interact with Research and Early Development departments on issues relating to electronic data capture, analysis and reporting. May also include Regulatory submissions

• Take the lead on evaluating and implementing additional technologies that may improve the overall quality of systems throughout all departments

• Consult with department representatives to determine business requirements as well as technical requirements for data access, reports, and interfaces

• Drives process improvements and efficiency and develops processes required for the successful implementation of key software systems

• Other duties as assigned

Requirements:

• BS/BA degree in computer science, IT, or similar field and 8+ years of IT experience; working in a pharmaceutical company with exposure to FDA regulations preferred. Recent experience implementing and in support 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 OR

• Master’s degree in computer science, IT, or similar field and 6+ years of similar experience noted above

• PMP certification or working towards certification highly desired

• Has knowledge of IT best practices in Research and Disco