Novavax
  • 13-May-2021 to 14-Jun-2021 (EST)
  • IT/IS
  • Gaithersburg, MD, USA
  • Full Time - Exempt

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.

We are seeking an IS Business Analyst III, Medical for this position that will be responsible for the following.

Responsibilities include but are not limited to:

  • Serves as functional resource and subject matter specialist for Medical Affairs 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
  • 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)
  • IT Experience with Digital Content management, Medical Information Systems, Medical Congress Planning, Product Complaints, Adverse Events, and Investigator-Initiated Studies (IIS),
  • Experience with any of the following Medical solutions highly desirable: Veeva MedComm, Datavision/iEnvision, MedInfo Database
  • Computer System Validation (CSV), and GAMP5 experience a plus
  • 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.

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