HomeJob Details
Return To Job List

Sr System Engineer, Regulatory and Content Management Systems – Clinical Informatics

Location: Norwood, Massachusetts
Job Category:


Sr System Engineer, Regulatory and Content Management Systems – Clinical Informatics

Location:             Cambridge / REMOTE

Reports to:         Associate Director, Regulatory and Clinical Informatics Platforms


The Role:


As the lead technical resource for the content management systems team,you'll integrate leading practices for content and workflow management for the Vault R&D platform with Moderna's Digital team informatics capabilities. You'll ensure our content management platform is reliable, compliant and scalable to support Moderna's extensive portfolio. You'll support colleagues in regulatory operations, clinical, medical affairs and commercial, enabling them to get the most value out of our digital platforms.


Here’s What You’ll Do:

  • Define and manage application enhancement process and release management for R&D Vault applications including Veeva Vault eTMF, Veeva Vault RIM, Veeva Medcomms and Veeva Promomats
  • Provide daily operations support to business groups including system usage, creating and updating reports, enhancements to existing configuration – workflows, document lifecycle, security, objects, user account management
  • Conduct requirements gathering sessions, capture business requirements, assist in end user training
  • Perform Change management activities in GxP environment including authoring and getting changes reviewed and approved in ServiceNow
  • Maintain all system related digital SOPs, WIs, system administration guides to keep content Gxp compliant
  • Manage, communicate and being able to deliver on competing priorities for system related activities
  • Design and perform integrations activities for data and content extracted from and to the Veeva platform
  • Experience with authoring and executing Veeva API calls for documents and objects
  • Utilize project management tools like smartsheets, confluence etc.
  • Lead meetings with business partners, capture meeting minutes and author project related documentation
  • Utilize Vault loader to migrate and upload object records and documents in Veeva
  • Able to use VPKs (Veeva Migration Packages) to move system changes from one environment to another
  • Define and execute integration strategy for regulatory and clinical content management in the Moderna digital ecosystem
  • Collaborate with Veeva QA Vault owner on platform-wide changes adoption and coordinate quarterly Vault releases

Here’s What You’ll Bring to the Table:

  • 7+ years' experience as a system manager/solution architect
  • Bachelor's degree in Computer Science, Biotechnology, or equivalent required. Master's preferred.
  • Deep and proven expertise with Veeva Vault R&D platform (Veeva Vault Admin certification preferred)
  • Working knowledge of CSV concepts for SaaS GxP applications and robust understanding and practice of change management
  • Tangible track record in using Agile approaches in a regulated environment
  • You can bring content, data, and workflow together to enhance business processes and combine automation and integration to make easy things easy and hard things possible
  • You have a working knowledge of clinical, regulatory, med affairs and commercial business processes. You work independently yet engage proactively with team members, colleagues, and stakeholders to get alignment and drive solutions forward.
  • You don't hesitate to dive in and work alongside your team. You can effectively manage conflicting priorities in a fast-paced environment, and you can navigate ambiguity and lead a team effectively if needed
  • You put the team before tasks by collaborating actively with all team members and supporting them.
  • Working knowledge of python or other programming languages to enable integrations preferred

Return To Job List

Apply For This Position - Sr System Engineer, Regulatory and Content Management Systems – Clinical Informatics

*First Name:
*Last Name:
Cover Letter:
Please enter characters below and submit:

Return To Job List