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 to include documents that work with sponsor and/or regulatory agency software programs meeting consistency and security issues.
Ensures that all final electronic deliverables meet current regulatory electronic document requirements and guidance under general supervision of the Manager, Regulatory Publishing and assistance as appropriate from a Senior Regulatory Publishing Specialist.
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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 action.
Evaluates the publishing needs in relationship to the overall project timelines, quality and delivery.
Engages other project team members, functional units or publishing management as necessary to deliver final product and resolve/mitigate identified 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 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 a 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.