JVT Advisors

Sr. System Engineer, Regulatory & Content Management Systems

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Location: Cambridge, Massachusetts 02139
Employment Type: Contract

Job Description

Contract Length:  6 months, 100% remote

Job Summary:  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 the company’s digital team informatics capabilities. You'll ensure the content management platform is reliable, compliant and scalable to support the company’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.

 

Responsibilities:

  • 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

Requirements:

  • 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
  • Working knowledge of clinical, regulatory, med affairs and commercial business processes

 

Chintan “Calvin” Raval

Vendor Operations Manager/Senior Recruiter

As the vendor manager for the Contract Recruiting team, Chintan is responsible for contract negotiation, continuing to expand relationships with IT service providers, and functional reporting including metrics for billability, operational issues, and investigated root causes.

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