RA Specialist

Description

• Engages with cross-functional teams and independently manages deliverables with SME confirmation. Must effectively communicate without authority.
• Facilitates discussions to explore data challenges with the goal of driving sound decisions. Where appropriate, pushes for most favorable outcomes and solutions.
• Embraces digital and technological strategies to improve outcomes. Identifies opportunities, assess’ s for practicality, and builds sensible justifications. Including being a representative on business process validation and implementation.
• Demonstrates excellent communication skills; listens to audience and tailors messaging appropriately. Builds and leverages network to proactively address challenges and champion improvements.
• Facilitates, and when required, leads cross functional team meetings.
• Support harmonization process for efficiency
• Update and maintain procedures

Key Performance Indicators

• Supports drug product registration data and submission process through the accurate and timely completion of activities.
• Make and support decisions with independently clear actions
• Effectively prioritizes competing tasks in a fast-paced and dynamic environment.
• Develops and supports process for data governance creation and update
• Follows all procedures and proactively maintain all training I system/ information.
• Perform duties with the highest ethical standards, delivering only high-quality, compliant submissions to FDA.
• Accepts responsibility for results and outcomes and honors all commitments.
• Is a cooperative partner and works well with others for the benefit of the organization.
• Maintains a high degree of professionalism; builds trust with leadership and peers.
• Demonstrates ability to maintain focus and performance when faced with emergency situations; recovers from setbacks and demanding activities.
• Communicates confidently with superiors and peers; is transparent in all requests and responses.

Qualifications