Laurie Nygren

About Laurie Nygren

SUMMARY I have 10+ years experience managing & supporting GxP & non-GxP systems, digital properties & projects for large, complex organizations. Thrive on driving entire project lifecycle from discovery to delivery through cross-functional teams & internal/external partners to successfully deliver initiatives on-time, on-budget Love processes—for clarity, focus & closure they bring Enjoy taking something complicated, messy & hard to understand, & making it simple, clean & easy to follow Use metrics & analytics to help business units gain insights, make data-driven, strategically-guided decisions & perform more efficiently Committed to employing best practices, collaboration & client satisfaction Wearing different hats in all my positions throughout my career has allowed me to use, develop & learn a variety of transferable skills. I honestly enjoy doing all these things & roles that allow me to continue to use, develop & learn new skills. Hard Skills: Veeva Vault Platform Certified Application Lifecycle Management Project Management Document & Content Management Business Analysis Business Process Documentation Reports & Dashboards Web Development Graphic Design Soft Skills: Collaboration, Cooperation & Teamwork Empathy & Understanding Adaptability & Flexibility Problem-Solving & Creativity Self-directed, Resourceful & Learn New Things Quickly Organization & Attention to Detail Time & Pressure Management Enthusiasm & Sense of Humor HANDS-ON EXPERIENCE & SPECIALTIES System evaluation, analysis, implementation, integration, configuration, administration, management, maintenance & enhancement Process development, implementation, management & improvement Project & vendor management Change management QA & UAT Documentation generation & maintenance User support & training Multimedia design, development & production Hand-coding HTML5 & CSS3 SEO & accessibility Information architecture & user-centered experience Metrics, analysis & reporting CAPABILITIES & SYSTEMS Document, Content & Asset Management—Veeva Vault, Sitecore, WordPress, SharePoint Customer Relationship Management—Veeva CRM Med Affairs & Med Info Systems—Veeva Link, Komodo Medical Information Cloud, iEnvision Project Management—Jira, Confluence Web Development—HTML5 & CSS3 coding, Responsive design, W3C standards, Section 508 guidelines Graphic Design—Adobe Photoshop & Illustrator Email Campaigns—Constant Contact, MailChimp e-Forms—SurveyMonkey, SurveyGizmo Metrics & Analysis—Qlik, Google Analytics Documentation & Presentations—Word, PowerPoint, Excel

Experience

1. Senior IT Business Systems Analyst, Information Technology - Quality & Techops Systems

   Apellis Pharmaceuticals

   Jul 2023 — Present · Waltham, MA, US

   Over the past two months, served as a system administrator and IT business analyst supporting GxP systems for Quality and TechOps. Focus was on building relationships, learning about the business and their processes, understanding the business needs, gathering business requirements, documentation, system administration and enhancements, system implementation support, and learning about computer system validation (CSV), FDA 21 CFR Part 11 and change control. Worked with all levels of the business, business owners and stakeholders, internal and external technology teams/partners, and external vendors. Key business systems include Veeva Vault and Kallik Veraciti. Supported operations and management of Veeva Vault Quality, including: Troubleshooted and resolved issues. Reviewed and discussed change requests and solutions with the business. Provided end user support. Performed quality assurance (QA) testing. Configured and tested QualityDocs Process Navigator. Reviewed application configuration and setup, and learned about deviation, CAPA, and complaint processes and management. Supported implementation of new artwork and labeling management system, Kallik Veraciti, including: Created first draft of system impact assessment (SIA). Worked with business owner and project team to generate user requirements specification (URS) document. Performed pre-dry run of test scripts and user acceptance testing (UAT). Learned about artwork and package labeling processes, procedures and management.

Education

• Wheaton College

  Bachelor of Science (BS), Kinesiology