IT Systems Analyst III

San Francisco, CA, United States
Apr 20, 2019
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Partners with IT Technical Leads to help implement and support R&D systems in compliance with the appropriate regulatory standards (GxP/21 CFR Part 11) and follow best practices within the pharmaceutical/biotech industry.

Collaborates closely with R&D Business Owners and IT Compliance (when required) to support existing (GxP and non-GxP) systems, and particpates in core operational activities in accordance with Nektar's SOPs. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Uses professional concepts to contribute to development of company's concepts and principles and to achieve objectives in creative and effective ways. Works on extremely complex problems in which analysis of situations or data requires and evaluation of intangible variables. Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Acts independently to determine methods and procedures on new assignments.

Coordinates the implementation of GxP systems (40%) and performs administration and operational support including user and security management (60%) in compliance with relevant policies, guidelines, and procedures. Works with Business System Owner, IT System Owner, IT Technical Leads, IT Compliance and other groups for all GxP (Clinical, Regulatory, Safety) applications such as Elluminate, Rave, Veeva, LIMS or similarly classified applications, coordinating downtimes for project related upgrades, updates, and configurations. Assist with solutions identification, evaluation, selection, implementation, testing, and working with the IT Apps team(s) to meet and exceed business requirements. Assist the systems validation process executing test scripts as required. Responsible for maintaining the validated state of IT GxP applications to ensure compliance to regulatory standards. Works with IT Compliance for for timely closure of CAPAs and Deviations. Participate/work with designated teams as an SME during Regulatory Audits and Inspections. Participate in troubleshooting, root cause analysis and impact assessment of R&D computer applications. Provide technical expertise for the support of existing systems, escalating and coordinating resolution with the vendor when required. Drives implementation/upgrade & support of GxP applications systems with comprehensive consideration of user requirements, systems integration, and project timelines. Analyze system needs, documents requirements and revises existing systems and develop test plans. Leverage in place project management system to assist in measuring, managing, and planning GxP system initiatives. Ensures GxP compliance requirements are met and/or exceeded on designated activities.Lead and support other projects as assigned.

A minimum of a Bachelors degree in a Computer Science, Information Systems or related discipline is required. Equivalent experience may be accepted. A minimum of 5 years industry work experience is required with 3 years of practical work as System Analyst in a life sciences/healthcare organization. Strong core IT fundamentals background accompanied with knowledge of R&D as well as GxP systems. An ability to support critical GxP Applications such as Veeva ( eTMF, RIM), Rave EDC, LIMS, vizualization tools and other classified systems in R&D portfolio. Knowledge of validation lifecycle of GxP computerized systems. Strong analytical skills to identify and resolve problems and ability to effectively apply a broad range of professional concepts, practices and methods in moderately complex and diverse circumstances are required. The ability to effectively assess end-user issues, demonstrating the ability to resolve and integrate solutions. The ability to understand and evaluate organization-wide impacts of application changes. A working knowledge of 21 CFR Part 11, Computer Systems Validation, GAMP framework and Change Control Process in Life Sciences industry. Experience with electronic ticketing and document management systems such as: FootPrints, ServiceNOW and MasterControl EDMS. Experience with client/server architecture, general networking concepts, office and desktop applications: Access, Word, Excel, PowerPoint, Outlook SmartSheets, etc. Excellent communication skills with the ability to present ideas in a clear succinct manner, both verbally and in writing are required. Must be able to work independently and efficiently on several tasks at once .

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.