Reg Publishing Spec

Thermo Fisher Scientific Inc.; México; A distancia; MXN 400,000 - 600,000; Jornada completa

Descripción de la vacante

A leading company in scientific manufacturing seeks a Regulatory Publishing Specialist to coordinate electronic submissions. This role involves ensuring compliance with regulatory standards, preparing necessary documentation, and managing unique technology requirements. Candidates should possess a Bachelor's degree and relevant experience, with strong skills in project management and communication.

Formación

• Bachelor's degree or equivalent formal academic/vocational qualification.
• 2+ years of relevant experience in regulatory publishing.

Responsabilidades

• Coordinates and manages client electronic submission deliverables for compliance.
• Assists in preparing electronic documents for regulatory publishing.
• Ensures final electronic deliverables meet regulatory requirements.

Conocimientos

Project Management

Regulatory Compliance

Document Preparation

Communication

Educación

Bachelor's degree or equivalent

Descripción del empleo

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Essential Functions and Other Job Information

Coordinates and manages client electronic submission deliverables supporting regulatory compliance.

Assists in preparing electronic document outputs that meet requirements for regulatory publishing, including documents compatible with sponsor and/or regulatory agency software programs, ensuring consistency and security.

Ensures that all final electronic deliverables meet current regulatory electronic document requirements and guidance under the supervision of the Manager, Regulatory Publishing, and with assistance from a Senior Regulatory Publishing Specialist.

Assists with developing and implementing project-specific processes for sponsors with unique technology requirements and may act as the company's liaison for electronic submissions with the sponsor.

Exercises judgment within defined procedures and practices to determine appropriate actions.

Evaluates publishing needs in relation to overall project timelines, quality, and delivery.

Engages other project team members, functional units, or publishing management as necessary to deliver the final product and resolve or mitigate issues or barriers to delivery.

Acts independently within a project team to evaluate and deliver publishing tasks.

Qualifications: Education and Experience:

Bachelor's degree or equivalent and relevant formal academic/vocational qualification.

Previous experience providing 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 such as protective eyewear, garments, and gloves is required.