Cook Group

E-commerce & Marketing Collective.

Senior Regulatory Affairs Operation Specialist, Data Integrity

ComplianceComplianceFull TimeRemoteTeam 11-50H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

11 days ago

Salary

Not specified

Bachelor Degree2 yrs expExperience acceptedEnglishCloudVault

Job Description

• Support the governance and review of Regulatory Affairs data integrity • Support digital transformation projects • Assist with on-boarding and integration of a new regulatory information management system • Support the implementation, launch and maintenance of new systems and processes • Work across multiple functional projects to understand data usage and implications for data integrity • Identify various sources of data and oversee the extractions of source data to ensure integrity • Identify data mapping rules, ensure data quality and timelines • Assist in designing, planning, and managing the data migration process • Work with other subject matter experts and project teams to identify, define, collate, document, and communicate data requirements • Participate in data migration plans including migration risk, milestones, quality, and business sign-off details • Lead various teams to clean, transform, match, and populate migration templates to ensure data integrity • Manage assigned risks and monitor potential impacts as part of the data migration plan • Provide Statistical reports of data moved, transformed, cleansed, and loaded

Job Requirements

  • Bachelor's of Science degree in Regulatory Affairs or relevant scientific or life science field and two (2) years of experience in Regulatory Operations
  • Will accept a Master’s Degree in lieu of the Bachelor’s degree and two (2) years of Regulatory Operations experience
  • Additional experience must include managing and publishing regulatory submissions for investigational or marketed products
  • Configuration and vault loader functionality in Veeva Vault RIM
  • Industry standards, regulations, guidelines related to regulatory submissions for medical devices
  • Experience with multiple cloud-based RIMS systems (such as Veeva) in Regulatory and Regulatory Content Management

Benefits

  • Support the governance and review of Regulatory Affairs data integrity
  • Support digital transformation projects
  • Assist with on-boarding and integration of a new regulatory information management system
  • Support the implementation, launch and maintenance of new systems and processes
  • Work across multiple functional projects to understand data usage and implications for data integrity
  • Identify various sources of data and oversee the extractions of source data

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