R&D BUSINESS ANALYSTR&D Business Analyst
Compensation is DOE (target is ~120-135k and bonus and RSUs)
San Diego, CA 92121 (UTC)
Up to ~20% Travel
• 3-5yr+ years of experience working as a Business / System Analysis within R&D IT environment
• Experience in Life Sciences
• Business Analysis, Requirements Analysis, Project Management
• System Validation
Desired (strong mix of the following):
• Familiar with CTMS (Clinical Trial Management System) /EDC (Electronic Data Capture) applications and related technology/processes
• Familiar with Quality Management Systems and related technologies such as MasterControl, Electronic Document Management System
• Hands on working knowledge of SAS as an implementer – installed, configured and supported SAS applications
• Veeva R&D suites specifically Submission & Registration Vaults
• Understanding of SDLC and CFR Part 11
• Agile Project Management
• PMP Certification
• Life Sciences Analytics Experience and familiarity with various tools such as Spotfire/EAST
• Knowledge/Experience with the IT Infrastructure Library (ITIL) framework
• MS SharePoint Online, Office 365 experience
• Bachelor’s Degree in IT, IS, or similar
• Understanding the Business - Will know the business and the mission-critical technical and functional skills needed to do the job; understands various types of business propositions and how businesses operate in general; learns new methods and technologies easily.
• Communicating Effectively - Writes and presents effectively; adjusts to fit the audience and the message; strongly gets a message across.
• Ability to work well within a team to learn and share knowledge
• Ability to speak the user’s language when talking to the business and the ability to speak technology when devising the solution with other colleagues in IT
• Have keen sense of quality awareness to support regulated system processes
• The individual will work closely with clients to understand their business, the challenges they face, and how best to introduce technology as an enabler to support them in achieving their goals and operational effectiveness.
• The candidate should be able to provide valuable thought leadership that helps drive business success. They should be comfortable listening and understanding business needs, asking insightful questions, and working with a team to solution and execute on the solution.
• Portfolio Management in this position outlines your responsibility for managing the business / client requests and working with the Director of R&D IT in demand planning, portfolio and financial management for all IT engagements.
• Project Ownership as a responsibility requires you to drive execution of key projects as well as understand how they work and integrate into the business ecosystem.
• Perform business and functional analysis activities for projects as required. Analyze business requests to determine the best approach to creating successful resolution delivery solutions/projects effectively and efficiently.
• Process understanding and documentation. Ensure that project documentation is complete and all Quality requirements are executed upon.
• Ensure that all customer expectations have been met through delivery of services or projects
• Analyze and understand existing system landscape utilized by R&D, identify opportunities for improvement and make proposals for solution implementation
• Create, manage and maintain process diagrams and process definition documents
• Gathering and analyzing requirements to improve existing processes
• Evaluate processes and existing technology and platform and their ability to provide efficient and effective control in relationship to industry "best practices"
• Be the “Go To” resource for business users in troubleshooting 2nd level system issues
• Performing the role of project manager in leading and managing implementations of on-premise as well as 3rd party applications.
• Assess business needs, scout for technology solutions in the market and onboard optimum solution to enhance business productivity.
We’re looking for an experienced Business Analyst that will report to the Director of R&D IT. This role will partner with leaders in the R&D and QA, to ensure delivery of information technology solutions that generate business value. This role will also interface with other IT team members and partnering business functions to ensure successful alignment across groups.
The IT Business Analyst -R&D role engages with business users to understand and document detailed business requirement, workflows, reporting specifications and help define operational system processes. This position requires having a good understanding of Pharmaceutical R&D business processes specifically in the areas of Clinical Operations, Clinical Development, Regulatory Affairs & Quality Systems. This person will have the ability to analyze and understand the usage of existing system landscape both on-premise as well as COTS/SaaS solution capabilities and create detailed business requirements for implementation using the right fit model. The position also requires strong project management, written and verbal communication skills and an ability to collaborate with management, users and other teams within the organization.
The ideal candidate will be well versed in technologies used in R&D and Quality such as CTMS/EDC, SAS, Veeva, Master Control, EDMS and other analytical software packages. Role works with department leads to identify opportunities, develops business cases, defines requirements and works closely with counterparts and the project team to ensure successful system implementations and their support.
• Pharmaceutical company focused on treatments for liver diseases
• ~600+ Employees
• Publicly Traded
• Founded in 2002
• Health, Dental, and Vision (multiple plans), FSA, HSA
• Matched 401k
• Strong PTO – 20 vacation days and 9 holidays
• Life and Disability Insurance
• Commuter Spending Plan
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