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Regulatory Information Management Data & Document Specialist

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The Regulatory Information Management Data and Document Coordinator will work within a team environment actively engaging with and remediate regulatory data and content within Veeva Vault RIM for investigational and commercial products.

This role will work daily in maintaining the data records of health authority dossiers related to applications, submissions, regulatory objectives, registered clinical studies and commitments. It will require updating and ensuring correctness for primary source document classification related to the ICH Common Technical Document hierarchy. Role will monitor compliance for data field entry and accuracy by global regulatory affairs users using a variety of reports and/or dashboards. In addition, participation in related departmental and cross-functional initiatives related to the expansion of Vault RIM capabilities and features is an opportunity to observe and learn the operational technicalities for Vault RIM supporting the drug development process

The role is expected to take direction from various levels of management, be collaborative in working style, have focused attention to detail and ask questions as needed.

To be successful in the role a desire to learn pharmaceutical regulatory industry regulations for health authority submissions, the tracking of regulated data and the nuances that impact these items depending on the particular region / country / application type is paramount.

Key responsibilities

  • Learn, and effectively use Veeva Vault RIM to support data entry, monitoring, compliance and reporting efforts
  • Create, update and mange Vault RIM object records across the platform for all aspects of regulatory operations
  • Run reports to check effectiveness of GRA end-user data entry and compliance
  • Organize, stage, import, index and manage submission documentation in an accurate and timely manner in assigned work projects as required
  • Provide routine status updates on progress, suggest process changes if applicable from hands-on experience

Competencies and Skills

  • High aptitude to learn and use new computer system application
  • Planning and time management skills, including a demonstrated ability to organize work and establish priorities and meet established timelines
  • Detail-oriented with the ability to promptly assess data and documents for accuracy as well as consistency
  • Must like to talk to co-workers at all levels, be able to engage in a clear and concise manner when providing direction or updates
  • Ability to work in a departmental and cross-functional team environment as a contributor
  • Ability to work independently for stretches of time while maintaining productivity levels

What you will learn

  • Knowledge of the drug development process, Non-eCTD and eCTD/ICH requirements and related guidance
  • Veeva Vault RIM applications of Submissions, Submissions Archive and Registrations
  • Domestic and international submission types and how such records are used in various countries for Health Authority applications