**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.