Temp to hire needed in Irvine CA. Strong writing and organizational skills required.
Summary: Under supervision, processes Advertising and Promotional Submission documentation for 2253 Regulatory Filings. Works with subject matter experts in Marketing, Marketing Operations and Regulatory Affairs to download, QC and obtain internal approval for Advertising and Promotional documents. Prepares regulatory compliant submission packages and has authority to submit routine health authority dossiers.
• Ensures technical accuracy and regulatory compliance of routine submissions for assigned products. Manages heavy workload and prioritizes projects, and provides load-balancing with peer(s) on a daily basis in a fast-paced environment.
• Coordinates resources and contacts internally to ensure deadlines are met and provides feedback to concerned parties to ensure continual process improvement.