Business Wire
Public Relations • Press Release Distribution • Investor Relations • SEC filing • SEO
501 - 1000
Manager - Submission Operations Management
6 days ago
Business Wire
Public Relations • Press Release Distribution • Investor Relations • SEC filing • SEO
501 - 1000
Description
• Oversee end-to-end dossier execution activities including submission planning. • Manage internal Submission Operations Management personnel, vendors and consultants. • Lead the development and implementation of standards for publishing, archiving, metrics and submission processes. • Monitor and assess business trends for potential regulatory operations impact. • Collaborate cross functionally within and outside of RA for submission operation expertise.
Requirements
• BS/BA with 5+ years or relevant experience in regulatory operations. • Significant experience within a Regulatory Publishing environment including hands on eCTD experience. • Ability to effectively operate both independently and as part of a cross functional team. • Ability to multitask and work under pressure and tight deadlines. • Working knowledge of regulatory guidelines. • Experience managing complex submission publishing activities.
Benefits
• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness
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