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PV RA MW Coordinator

hace 2 meses

Xico, México Thermo Fisher Scientific A tiempo completo

Job Summary:

Thermo Fisher Scientific is seeking a highly skilled PV RA MW Coordinator to join our team. As a PV RA MW Coordinator, you will play a critical role in ensuring the quality and compliance of our regulatory publishing documents.

Key Responsibilities:

  • Provide support and coordination of review of safety and regulatory publishing documents on receipt, ensuring timely and accurate processing.
  • 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, adhering to strict confidentiality and data protection protocols.
  • Assist in maintaining the upkeep of licenses within internal and/or external systems for users across projects within IT Security standards, ensuring seamless access and compliance.
  • Coordinate/facilitate project meetings, draft meeting minutes, post minutes/materials to client portals, and distribute to internal and external project teams, fostering effective communication and collaboration.
  • Manage project-specific training and the set-up, maintenance, and archival of program files, ensuring audit readiness and compliance with regulatory requirements.
  • Perform data entry into internal/external databases, tracking systems, and PPD's budget management system, identifying and resolving issues that may impact project timelines.
  • Oversee expenses and manage translations, ensuring budget parameters are not exceeded, and maintaining financial transparency.
  • Assist with archiving of regulatory publishing documents and submissions, ensuring compliance with regulatory requirements and company policies.

Qualifications:

  • Education and Experience:
  • 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).