Regulatory Publishing Specialist

hace 1 mes


Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

Job Summary

We are seeking a highly skilled Regulatory Publishing Specialist to join our team at Thermo Fisher Scientific. In this role, you will be responsible for coordinating and managing client electronic submission deliverables to support regulatory compliance.

Key Responsibilities

  • Coordinate and manage client electronic submission deliverables to ensure regulatory compliance.
  • Assist in preparing electronic document outputs that meet regulatory requirements, including documents that work with sponsor and/or regulatory agency software programs.
  • Ensure that all final electronic deliverables meet current regulatory electronic document requirements and guidance.
  • Develop and implement project-specific processes for sponsors with unique technology requirements.
  • Exercise judgment within defined procedures and practices to determine appropriate action.
  • Evaluate publishing needs in relation to project timelines, quality, and delivery.
  • Engage other project team members, functional units, or publishing management as necessary to deliver the final product and resolve/mitigate identified issues or barriers to delivery.

Requirements

Education and Experience: Bachelor's degree or equivalent and relevant formal academic/vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

Working Conditions and Environment

Work is performed in an office/laboratory and/or clinical environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Personal protective equipment required such as protective eyewear, garments, and gloves.



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