Reg Publishing Spec

Work Schedule

Environmental Conditions

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. 
 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.