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Pv Ra Mw Coordinator/ Experience In Regulatory Publishing

hace 2 meses

Xico, México Thermo Fisher Scientific A tiempo completo

Job Summary

We are seeking a highly organized and detail-oriented Pv Ra Mw Coordinator to join our team at Thermo Fisher Scientific. The successful candidate will provide support and coordination of review of safety and regulatory publishing documents, ensuring timely and accurate submissions.

Key Responsibilities

  • Provide support and coordination of review of safety and regulatory publishing documents on receipt.
  • Assist in reviewing document quality when tracking safety and regulatory publishing data in internal systems and uploading in internal and/or external electronic trial master files.
  • Ensure redactions for Commercially Confident Information and Personal Data for regulatory publishing is maintained.
  • Assist in maintaining the upkeep of licenses within internal and/or external systems for users across projects within IT Security standards.
  • Coordinate/facilitate project meetings, draft meeting minutes, post minutes/materials to client portals and distribute to internal and external project teams.
  • Manage project specific training and the set-up, maintenance and archival of program files; ensuring audit readiness.
  • Perform data entry into internal/external databases, tracking systems and PPD's budget management system; perform system reconciliations to identify issues which may negatively impact project timelines.
  • Oversee expenses and manage translations; ensuring budget parameters are not exceeded.
  • Assist with archiving of regulatory publishing documents and submissions.

Qualifications

  • High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
  • Technical positions may require a certificate
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years)