Job Type

full-time

posted

8 days ago

Location

Bothell, WA

Description

 


 

About USDM




 




USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.




 




As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?




 




Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.




 




The Principal/ Senior IT Systems Analyst is a key member of the IT Business Solutions team and is responsible for deploying, configuring, implementing validated technology systems at Client; acting as subject matter expert where appropriate; and providing ongoing process and enhancement support post-implementation for Veeva Vault and other associated Clinical Systems




Principal Responsibilities:







  • Responsible for the implementation and ongoing support of validated IT applications, including on-prem server-based applications, laboratory systems, and SaaS solutions



  • Complete upgrades and enhancements to existing applications 



  • Requisition application servers and assist in application installation 



  • Participate in GxP validation/qualification of systems including writing, reviewing, and executing validation protocols 



  • Identify gaps between business needs and technical capabilities; work to find innovative solutions that meet business objectives or create new business opportunities 



  • Create user documentation and train personnel on applications/reports/solutions, as required 



  • Represent the needs of our customers to the solution vendor(s) 



  • Author and refine system support processes, flow diagrams, configurations, and interdependencies 



  • Develop effective working relationships with our internal customers and vendors during project meetings, on-site visits and conference calls 



  • Assists our internal customers in developing working scenarios for testing 



  • Communicate support issues, solutions and progress to management 



  • Manage the application integrations across Vault Clinical landscape






Principal Analyst responsibilities (in addition to Sr.Analyst responsibilities)







  • Global Clinical Architecture and Roadmap – strategizing, prioritizing, and driving on the future state business needs



  • Lead plan & deliver new and / or existing strategic platform capabilities that create tangible business value






Qualifications:




Requirements







  • Experience in supporting and implementing large scale IT solutions 



  • Demonstrated technical understanding of application architecture to include application servers, web servers, configuration files, relational databases, SQL, and reporting applications 



  • Experience with basic scripting, command line execution, development of batch files 



  • Proven knowledge of IT solutions and application management through various product cycles and business environments 



  • Ability to prioritize and quickly adapt to changing situations 



  • Strong interpersonal skills, with a high degree of self-motivation and ability to work independently 






Preferred 







  • Previous experience supporting a Veeva Vault system, specifically, Veeva Vault Clinical suite (eTMF, CTMS, CDMS modules) 



  • Familiarity with biotech/pharma business processes and applications 



  • Familiarity with GxP and ICH regulations and 21CFR, Part 11 






Education and Experience:







  • 10+ years’ experience (12+ years’ experience for a Principal Analyst role) with bachelor’s degree or 8+ years’ experience (10+ years’ experience for a Principal Analyst role) with master’s degree in Business, Computer Science, Engineering or related discipline, or equivalent work experience






 

 

 

 

 

 

 

 

 

 

 

USDM Life Sciences is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

 

Disclaimer: This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

 

 

 

 

 

 

 

 

 

 


About the Company

Company Logo USDM Life Sciences
Company Logo USDM Life Sciences
Company Logo USDM Life Sciences
Company Logo USDM Life Sciences

USDM Life Sciences

Transformation and Innovation in Regulatory Compliance and Technology Life Sciences consulting firm with over 20 years experience in global compliance and technology. We offer bold solutions that accelerate innovation and compliance. Our team of subject-matter experts includes former FDA auditors and regulatory officials whose insight and oversight are part of every project. We have over 2 decades of experience working with hundreds of life sciences companies, enabling them to maintain compliance, optimize business operations, and reduce costs.

Company Size

500 to 999 employees

Industry

Other/Not Classified

Website

https://www.usdm.com/home