R&D Systems Analyst

We are seeking an R&D System Analyst to join our growing IT Enterprise Applications team.  This role will directly support R&D functions (including Clinical Operations, Clinical Development, Quality, Regulatory, and Biometrics) by driving system/business process optimization, managing system change controls, and supporting computer system validation (CSV) activities in a GxP-regulated environment. This role is centered around applications and tools used to oversee and document clinical trials, as well as the processes to collate and submit to health authority agency(s).

This role will serve as a key partner to both IT and R&D business stakeholders, ensuring our enterprise applications meet operational needs and regulatory requirements.  This position reports to the Associate Director, GxP R&D Systems within the IT Enterprise Applications team and plays a critical role in the lifecycle management of R&D systems such as Veeva Vault and other cloud-based applications.

Key Responsibilities

System & Business Process Analysis

• Partner with business teams to define business process(es) & user requirements
• Support definition of project scope and deliverables to support business goals
• Identities and troubleshoots technical and system/process issues to resolution
• Provide training/orientation/qualification to internal users when required

Change Control & Release Management

• Oversee vendor managed services resources
• Act as a liaison across R&D teams to ensure the highest level of quality customer service and product delivery

CSV & Compliance

• Participate in the authoring/review and execution of implementation plans/qualification tests
• Participate in the authoring/review of computerized system validation (CSV) documentation
• Execute and coordinate UAT cycles across GxP systems

System Administration and Enhancements

• Support enhancements, triage requests and backlog management
• Deliver solutions focused on establishing and improving business processes that improve efficiency, address process gaps, and enable automation and growth of the organization
• Ensure assignment and timely resolution of account requests, user issues and change requests
• liaise with computer system vendors, IT partners, Validation and the business to coordinate implementation activities

Ideal Candidate

• Bachelor’s degree (or equivalent professional experience) in Life Sciences, Information Systems, Engineering, or related field.
• 5+ years of experience supporting IT systems or business processes in a biotech, pharmaceutical, or regulated life science environment.
• Direct hands-on experience implementing technical solutions (workflows, reports/dashboards, objects, security) and validating GxP computerized systems
• Experience managing validated applications in a regulated environment
• Experience defining data transfer processes and standards and/or data integration processes
• Strong understanding and working knowledge of GxP Regulations (FDA, EMA, ICH), including FDA 21 CFR Part 11, 210 and 211
• Ability to communicate ideas in both technical and user-friendly language
• Self-motivated and passionate about learning and adapting to new technology. Must be able to deal with ambiguity and work through issues with agility without compromise to best practices and documentation
• Must have proven business and technology skills with success providing customer-oriented technology solutions
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Ability and willingness to travel up to 10-15%

The anticipated salary range for candidates for this role will be $125,000 - $140,000 year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.