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Senior, IT Business Systems Analyst

Employer
Novavax
Location
Gaithersburg, MD
Closing date
Sep 22, 2021
If you find science, speed, and success exhilarating, you have come to the right place.Novavax, Inc.?(Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.? Novavax?is currently conducting multiple late-stage clinical trials for NVX-CoV2373, our vaccine candidate against the virus that causes COVID-19, and has recently reported exciting and highly encouraging initial efficacy results. NanoFlu, our quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.?Novavax?is a leading innovator of recombinant vaccines. Our proprietary technology platform leverages the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.Novavax is seeking a Senior IT Business Systems Analyst.Responsibilities include but are not limited to:Serves as technical resource and subject matter expert (SME) for clinical and medical affairs platforms (eg Veeva eTMF Vault, Datavision, IIS).Acts independently to determine methods and procedures on new or special assignments.Participates in projects with varying levels of complexity.Responsible for gathering and documenting user requirements, functional requirements, technical requirements, in support of Clinical and Medical affairs systemsResponsible for creating design documents, qualification and data migration protocols for GxP and Non GxP systems if and as applicable.Perform system administration activities such as onboarding and off boarding end users, doing configuration changes, participate in system release and post-deployment support activities by working with Quality, System Owner, Business Owner, IT Operations, and IT Service Desk.Troubleshoots technical issues and manage problems through to resolution by working with Vendor.Responsible for deploying configurations changes and/or releases following IT Change Management (ITCM) and GxP Change Control procedures.Provides application support, including handling access request tickets, incidents and problems tickets related to Veeva eTMF vault and/or medical affairs applications.Document common resolutions/solutions and common application support processes in the IT Service Desk knowledge teracts with end users on a regular basis to understand their issues to provide resolution and guidance.Coordinating training activities, create training materials and train the end users if and as applicableTravel to other sites may be required.Minimum Requirements:Bachelor of Science or equivalent qualification level, preferably in computer science or engineering or life sciences or equivalent combination of education and experience is required.Experience in Life sciences industry will be preferred.At least 8 years of experience working with validated and regulated information systems.Excellent verbal and written communication skills.Ability to effectively work with diverse teams and under pressure.Strong technical background with understanding of SaaS application /COTS products, hands on experience on technologies and languages eg SQL, Java, AWS, SharePoint or other Cloud based platforms, experience with ETL tools etc.Knowledge of Veeva platforms is highly desirable. Veeva Vault certification is highly desirableOther IT-related certification(s) or equivalent experience.Practical knowledge and application of cGMPs (industry experience/awareness) especially relating to quality assurance processes and procedures.Must possess excellent customer service, problem solving, troubleshooting, and verbal/written communication skills.Subject matter expert on SDLC principles, Agile principles and industry best practices used for software development and deploymentComputer System Validation (CSV) and GAMP5 experience is highly desirable.Experience with any of the following clinical or medical affairs systems: Veeva eTMF vault, Veeva CTMS, Any other Veeva Vaults, Datavision, IIS/CRS etc.Experience with ITIL, COBIT, or other IT good practices desirable.Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.Equal Opportunity Employer/Veterans/DisabledNovavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.#LI-SH1Job SummaryRequisition Number: SENIO002121Job Category: Information TechnologySchedule: Full-Time

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