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IT Business Technology Analyst 3/Senior, Veeva
at Novavax Maryland in Maryland (Published at 08-10-2022)
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.
Summary of the Position :
We are seeking an IT Business Technology Analyst III, Veeva MLR to serve as technical resource and subject matter expert (SME) for MLR (Medical, Legal, and Regulatory Affairs) or clinical data platforms (e.g., Veeva PromoMats, CDMS).
Responsibilities include but are not limited to :
Veeva Vault Technical Support:
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.
#LI-SVH
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
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.
Summary of the Position :
We are seeking an IT Business Technology Analyst III, Veeva MLR to serve as technical resource and subject matter expert (SME) for MLR (Medical, Legal, and Regulatory Affairs) or clinical data platforms (e.g., Veeva PromoMats, CDMS).
Responsibilities include but are not limited to :
Veeva Vault Technical Support:
- Serve as the technical expert on the Veeva Vault products to provide recommendations on document and data migrations, integration, configuration, document and object lifecycles and workflows, security settings, report creations, bulk loads of documents, etc.
- Take part in being a vital role to the implementation of new systems and upgrades of existing systems. Provides technical leadership and subject matter expertise on projects to effectively manage business user expectations and timelines.
- Ability to coordinate with Managed Service technical support personnel where applicable.
- Works collaboratively with Commercial IT in the management of enterprise systems, the development and adherence of standards and governance, enterprise architecture and common infrastructure.
- Assist with territory and alignment technical operations as needed in Veeva Align.
- Serves as technical resource and subject matter expert (SME) for MLR (Medical, Legal, and Regulatory Affairs) or clinical data platforms (e.g., Veeva PromoMats, CDMS).
- 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 MLR or clinical data-related customer activities
- Responsible for creating design and xQ documents, and data migration protocols for GxP and Non GxP systems as applicable.
- Perform system administration activities such as onboarding and off boarding end users, conduct configuration changes, participating 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 Vendors and other resolving agencies
- 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 Vault (e.g. PromoMats) and/or clinical applications.
- Serve as the primary technical and operational expert for Novavax’s Veeva CRM system
- Manage salesforce.com data feeds and other integrations
- Support agencies of Sales Operations and the Commercial organization with CRM integration of Vault PromoMats materials
- Support sales campaigns, speaker programs, national sales meetings, and Veeva reporting, and other commercial initiatives
- Manage the planning, implementation, configuration, and ongoing administration of Novavax Veeva suite systems
- Ensure compliance with Novavax corporate policies and procedures
- Manage operational requests and assist in the escalated triage of support issues
- Receive and implement requirements from the business to continuously improve the Veeva platform
- 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 e.g. SQL, Java, AWS, SharePoint or other Cloud based platforms, experience with ETL tools etc.
- Strong knowledge of Veeva platforms. Veeva CRM or Veeva Vault certification is highly desirable.
- Experience handling data in a Salesforce environment.
- Understands integrations/APIs.
- Other 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 deployment
- Computer System Validation (CSV) and GAMP5 experience is highly desirable.
- Must be a team player and able to work with a diverse group of users and business partners.
- Strong communication skills.
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.
#LI-SVH
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
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