Layer, Chiang, et al. Genome Biology
Ardea Biosciences, Inc. a wholly owned subsidiary of Astra Zeneca based in San Diego is a Biotechnology Company focused on the development of small molecule therapeutics for the treatment of serious diseases.
Ardea Biosciences Regulatory Affairs team has a need for a temporary Regulatory Affairs Associate to join the team. The successful candidate will be responsible for providing support to Regulatory Affairs. In the process the candidate will gain knowledge of drug development in the Pharmaceutical Industry.
•Organizes and maintains confidential files and records.
•Assists regulatory operations with regulatory submissions, compiling both electronic and hard-copy documentation, preparing shipments and tracking shipments.
•Assists regulatory operations with tracking, logging, and maintenance of correspondence files.
•Review regulatory documentation packages prior to drug release to clinical sites
•Assists in the document upload and maintenance of the company-wide electronic document management system.
•Performs detailed quality control of data tables.
•Assist with formatting documents utilizing templates to assure consistency and adherence to style guide standards are met.
•Assist with publishing and document formatting QC to ensure compliance with industry and Company-defined standards.
•Assists with special projects as needed.
•Carries out job responsibilities and assignments safely and maintains a clean and safe work area.
•Other duties as necessary.
•Completed or currently in a two or four year program to earn a degree in business, computer science, social sciences, regulatory affairs, or related discipline.
•Prefer a minimum of one year's experience within a regulatory affairs role.
•Excellent and demonstrated skills in computer applications. Must have knowledge in Microsoft Word, Adobe Acrobat, Excel and Power Point; Access or other databases or document management systems (e.g., Livelink, Documentum, MasterControl, NextDocs) experience is a plus.
•Very organized and ability to multi-task and prioritize across a variety of responsibilities with direction, set expectations and provide deliverables as expected.
•High attention to detail, good written and oral communication skills, and the ability to work comfortably in a fast-paced and team environment.