Regulatory Affairs Associate

4 weeks ago


Foster City, United States Infotree Global Solutions Full time

Regulatory Affairs CMC – Data Administrator Contractor


Specific Job Responsibilities

§ Perform data entry using client 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.



Knowledge & Skills

§ 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



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