Sponsor: Rubicon Genomics
Recording Date: 2/19/2014
Recording Time: 1 hour
The successful Regulatory Operations Associate candidate will be responsible for formatting and publishing documents for paper or electronic Regulatory submissions. This individual will support the regulatory team to ensure documents are consistently compiled in accordance with industry standards and company policies.
• Provides Electronic Document Publishing support (i.e., scanning, rendering, bookmarking/linking, and document verification) for regulatory submission documents to industry and Company-defined standards.
• Formats documents utilizing templates to assure consistency and adherence to style guide standards are met.
• Provides assistance to authors of multiple functional areas to ensure documents are in the correct template and compliant with style guide.
• Perform publishing and document formatting QC to ensure compliance with industry and Company-defined standards.
• Compile regulatory submissions in paper or eCTD format.
• Assists with activities associated with preparedness for further eCTD filings; including SOP development, system testing and validation.
• Other duties as may be necessary.
• Bachelors in a relevant field.
• 3+ years of regulatory submissions experience, with at least 2 years’ experience with industry accredited software solutions.
• Experience with producing INDs, NDAs and MAAs in eCTD format.
• Experience in advanced user skills using Microsoft Word and Adobe Professional is required and experience with Octagon Starting Point templates is preferable.
• Prior experience with a document management systems (e.g., Documentum, Livelink, FirstDocs, FirstPoint, MasterControl), and submission publishing tools (e.g., ISI eCTD Express, CoreDossier) is required.
• Experience with Microsoft Excel, PowerPoint, and MS Project is desired, 2010 Microsoft Office preferred.
• Demonstrated organization, planning and follow-up skills as well as communication, teamwork and interpersonal skills.
• Able to work in a fast paced environment and multitask priorities.
• Ability to apply knowledge to new situations.
• Minimal travel is to be expected.
Interested parties please apply on-line at: www.ardeabio.com/careers
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 is seeking a Regulatory Operations Associate to join its’ dynamic team.