Sr. Regulatory Affairs Operation Specialist; Data Integrity

Overview

Sr. Regulatory Affairs Operation Specialist (Data Integrity)

Support the governance and review of Regulatory Affairs data integrity while supporting digital transformation projects, including standardization of all regulatory affairs data, processes and procedures globally. Assist with on-boarding and integration of a new regulatory information management system support alignment of regulatory with the clinical and marketing functions utilizing the platform. 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. Plan, manage and QC the completion of the migration templates. Manage assigned risks and monitor potential impacts as part of the data migration plan. Develop and govern best practice, processes, and standards for the digital transformation process.

Perform source system data analysis to manage source to target data mapping. Test static data and transaction data from one core system to another. Perform data migration audit, reconciliation, and exception reporting. Provide Statistical reports of data moved, transformed, cleansed, and loaded. Manage cross-program data assurance for physical data items in source and target systems.

• 1. Bachelor's of Science degree in Regulatory Affairs or relevant scientific or life science field and two (2) years of experience in Regulatory Operations.
• 2. Additional experience must include:
  • managing and publishing regulatory submissions for investigational or marketed products to global regulatory authorities in Veeva Vault RIM.
  • configuration and vault loader functionality in Veeva Vault RIM.
  • industry standards, regulations, guidelines related to regulatory submissions for medical devices and their application to Veeva Vault RIM constraints or configurations.
  • evaluating modifications in the Veeva Vault data model and their effects on regulatory data integrity and accuracy.
  • developing and implementing data remediation strategies within Veeva Vault RIM to enhance regulatory operational efficiency.
  • multiple cloud-based RIMS systems (such as Veeva) in Regulatory and Regulatory Content Management and source Product Management systems (Oracle PLM, Windchill, SAP, etc.)
• 3. May work remotely.
• 4. Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Cook Incorporated, 750 Daniels Way, Bloomington, IN 47404

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