Work Schedule

Environmental Conditions

Job Description

- Prepares and reviews regulatory submissions. 
- Provides regulatory strategy and/or technical advice to internal and external  clients, and acts as a liaison in executing strategies.
- Leads the development and implementation of project-specific processes for  sponsors.
- Collaborates with other departments, regulatory consultants, and  regulatory authorities.
- Assists in identifying and recognizing out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications. 
- Participates in project launch meetings, review meetings and project team meetings.
- Supports business development activities, including project budgeting/forecasting.
- Requires
• Not mandatory but preferred experience clinical trials submissions and development
• Good organizational and planning skills to effectively manage shifting priorities
• Capable of working effectively on a team and/or independently with minimal supervision
• Good electronic document production skills
• Good proficiency in several computer applications including Microsoft Office software
• Good attention to detail and quality of documentation
• Good interpersonal skills with the ability to interact with customers
• Solid verbal and written communication skills
• Capable of multitasking and managing multiple projects