Regulatory Affairs Associate II

• Perform data entry using Gilead Information Systems to enter and maintain relevant product information to support cross-functional stakeholders.
• Work collaboratively to support the RA CMC team to meet deliverables and timelines by executing routine data entry, quality control of that data entry and associated reports.
• Ensure completeness, correctness and consistency of data and data structure.
• Responsible for supporting project work for enhancements to information. systems for RA CMC and stakeholders who utilize RA CMC data.
• Responsible for development and acquisition of required system skills and knowledge; training supported by manager and peers.
• Work is performed under the general supervision of more senior Regulatory Affairs CMC Systems professionals.

Requirements:

• Should have familiarity with data entry into complex information systems.
• Should have familiarity with web-based Electronic Data Capture EDC and data management systems.
• Should have experience with Veeva Vaults, experience with the RIM Vault preferred.
• Strong verbal and written communication skills and interpersonal skills.
• Excellent organization skills and ability to work on multiple concurrent projects with tight timelines are required.