Regulatory Publishing Specialist
hace 4 semanas
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 publishing 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.
- Act as the company's liaison for electronic submissions with sponsors.
- Evaluate publishing needs in relation to project timelines, quality, and delivery.
- Engage with project team members, functional units, or publishing management to deliver the final product and resolve/mitigate identified issues or barriers to delivery.
Requirements
To be successful in this role, you will need a Bachelor's degree or equivalent and relevant formal academic/vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job is also required.
Working Conditions
This role will be performed in an office/laboratory and/or clinical environment. You will be exposed to biological fluids with potential exposure to infectious organisms, electrical office equipment, and may require personal protective equipment such as protective eyewear, garments, and gloves.
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