Senior Specialist, US Regulatory Affairs Operations

Title: Senior, Regulatory Affairs - Operations
Location: Athens, GA
Hours: Part-time
Type: Contract

Overview
Joule has an opening for a Senior Specialist within Regulatory Affairs that can work 2-3 days onsite in Athens, GA. The selected specialist must be able to work between 8 am to 5 pm, Monday-Friday as scheduled for 20 hours weekly. Must be adaptable and able to act quickly, with an open mind to face internal and external circumstances with customers, internal or external, and creating innovative ideas to respond to changing needs.

Responsibilities

• Intrapreneurial spirit while being rigorous and disciplined with compliance requirements.
• Strong attention to detail, must exhibit good judgment, and ability to problem-solve issues in daily work
• Able to meet stringent time and quality demands.
• Self-motivated with a high degree of initiative, commitment and persistence.
• Well-developed organizational capabilities and a strong team player who is collaborative with the mission of BI, but able to drive change.
• AAI Competencies and ability to take ownership for decisions and actions.

Requirements

• Bachelor's degree, preferably in science, and 3 years relevant industry experience OR associate's degree and 5 years of relevant industry experience.
• Demonstrated ability to successfully collaborate in a global organization and manage a full workload.
• Prior Clinical, regulatory experience.
• Ability to work onsite and part-time hours
• Effective communicator with good negotiation and interpersonal skills.
• Ability to form productive working relationships at all levels across disciplines and nationalities.