Job Description

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

Novavax, Inc.(Nasdaq: NVAX) is a late-stage biotechnology company that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases. Novavax is uniquely qualified to address the enduring need for innovative vaccines. We utilize our proprietary recombinant technology platform, which combines genetic engineering's power and speed to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. 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.

RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

• Serves as functional resource and subject matter specialist for Clinical Information Management Systems
• Acts independently to determine methods and procedures on new or special assignments
• Provides advice, guidance, and training to colleagues
• Makes recommendations on vendor selection and oversees vendor activities
• Participates in projects with varying levels of complexity
• Collects, documents, and manages user, functional, and technical requirements for regulatory information management systems for the vaccinesbiologics business space
• Manages application configuration changes following IT Change Management (ITCM) and GxP Change Control procedures
• Manages qualification/data migration protocols for supported applications
• Participates in system release and post-deployment support activities with Quality, System Owners, IT Operations, and IT Service Desk
• Provides application support for validated applications
• Interacts with 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 knowledgebase
• Travel to other sites may be required

MINIMUM REQUIREMENTS:

• Bachelor or equivalent qualification level, preferably in Biological Science or equivalent combination of education and experience is required
• IT-related certification or equivalent experience, project management experience preferred
• At least 8 years of experience working with regulatory information systems
• 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
• Practical knowledge of SDLC principles, industry best practices, and assigned system(s) (SDLC/ADLC)
• Content management, Trial Master File (TMF), SQL, Medidata, Computer System Validation (CSV), and GAMP5 experience a plus
• Experience with any of the following Clinical solutions highly desirable: Veeva, SAS
• Experience with ITIL, COBIT, or other IT good practices desirable
• Contributes to building high-performing teams
• Motivates self and others

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/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.

JOB POSTED BY APPLICANTPRO