SR/ Reg Publishing Spec

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.