Senior IT Business Analyst, Regulatory Systems

If you find science, speed, and success exhilarating, you have come to the right place.

Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world's most pressing infectious diseases. We have more than a decade of experience contending with some of the world's most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.

Our scientists are committed to developing vaccine candidates for some of the world's toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform. Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.

Job Summary

Novavax Information Technology seeks a Lead IT Subject Matter Expert (SME) responsible for all aspects of computer systems related to Regulatory. This position serves as a functional resource and subject matter expert for regulatory systems. The position reports to the Senior Director of Business Technology for Quality and Regulatory systems.

Essential Functions

• Serves as lead IT subject matter expert and functional resource for Regulatory Information Management (RIM) and submission publishing systems.
• Determines methods and procedures on new assignments, utilizing business process modeling, data modeling, and analysis.
• Partners with assigned client(s) to identify and evaluate systems and procedures for business solutions.
• Builds strong partnerships with clients and vendors.
• Participates in projects with varying levels of complexity; identifies, manages, and communicates risks associated with projects; may function as a project manager or team lead for projects.
• Collects, documents, and manages user, functional, and technical requirements for regulatory systems.
• Supports development of business cases; evaluates and qualifies opportunities for business process and technology improvements; and provides insight for development of multi-year strategic roadmaps.
• Manages application configuration changes following IT Change Management (ITCM) and GxP Change Control procedures.
• Participates in system validation, release, and post-deployment support activities with Quality, Validation, System Owners, IT Operations, and IT Service Desk.
• Provides application support for validated applications.
• Interacts with business process owners and end users on a regular basis to understand their needs and provide guidance and training on technical solutions.
• Troubleshoots technical issues and manage problems through to resolution.
• Develops processes to ensure high availability of supported application systems.
• Documents common resolutions/solutions and application support processes in the IT Service Management knowledge base.
• Travel to other sites may be required.

Supervisory Responsibilities

Not Applicable

Required Knowledge, Skills, and Abilities

• Bachelor or equivalent qualification level, preferably in Information Technology, Biological Science, or equivalent combination of education and experience is required.
• 8+ years of experience working with regulatory systems.
• Practical knowledge and application of cGMPs (industry experience/awareness) especially relating to regulatory processes and procedures.
• Must possess excellent customer service, problem solving, troubleshooting, and verbal/written communication skills.
• Practical knowledge of SDLC principles, industry best practices, and assigned system(s) (SDLC/ADLC).

Education, Experience, Licenses & Certifications

• IT-related certification or equivalent experience, project management experience preferred.
• Content management, Data Migration, PL/Transact SQL, XML, object-oriented design, Trial Master File, Computer System Validation (CSV), and GAMP5 experience a plus.
• Experience with any of the following Regulatory solutions desirable: Lorenz docuBridge, Veeva Vault RIM, Parexel InSight Manager, GlobalSubmit, ACUTA, eCTD review, and/or ISIToolbox.

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/Disabled

Novavax 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.

Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption.