Senior Regulatory Publishing Coordinator

hace 3 semanas


Xico, México Thermo Fisher Scientific A tiempo completo
About This Opportunity

We are seeking a highly skilled Senior Regulatory Publishing Coordinator to join our team at Thermo Fisher Scientific. In this role, you will be responsible for providing support and coordination of review of safety and regulatory publishing documents on receipt.

Key Responsibilities
  • 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, drafts meeting minutes, posts minutes/materials to client portals and distributes 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; performs system reconciliations to identify issues which may negatively impact project timelines.
  • Oversee expenses and manages translations; ensuring budget parameters are not exceeded.
  • Assist with archiving of regulatory publishing documents and submissions.
Requirements

To succeed in this role, you will need:

  • A 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).
What We Offer

In return for your expertise, we offer a competitive salary of $65,000 - $85,000 per year, depending on location and experience. You will also have access to a range of benefits including health insurance, retirement plans, and paid time off.



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