For our location in Wayne, PA (Greater Philadelphia area) we are actively seeking a
Publishing Consultant, Regulatory Operations
Your Tasks - as important as our Software:
- Publish submissions (new applications, supplements, amendments, annual reports, etc.) in the proper electronic format and submit to regulatory authorities via the Electronic Submissions Gateway (ESG) or equivalent submission portal utilizing in-house publishing software.
- Prepare documents for submission by scanning, rendering, bookmarking, and hyperlinking.
- Perform quality checks for document integrity and compliance to regulatory standards.
- Troubleshoot document issues and provide guidance to company employees on best practices and regulatory requirements.
- Prepare and maintain electronic templates that will be used company-wide for preparation of submission documents.
- Prepare and submit Structured Product Labeling/Drug Listings to FDA via the Electronic Submissions Gateway (ESG), as required.
- Prepare and submit Establishment Registrations to FDA via the Electronic Submissions Gateway (ESG), as required.
- Travel 25-50% of the time.
Your Profile - as good as our Solutions:
- Bachelor's degree (B.A. or B.S.) from a four-year college or university and one to two years of experience in electronic submission publishing.
- Experience with document management systems and publishing software (tools) to support paper and electronic submission publishing
- Working knowledge of eCTD structure and requirements
- Proficient with a Windows environment, including SharePoint, Outlook, Word and Excel, and Adobe Acrobat. Ability to implement new computer software with minimal supervision.
Still not enough? Our workforce of approximately 100 employees (we are growing fast!) is represented by 17 different nationalities - and we are all working towards one goal!