EXTEDO is the key software and service solutions provider in the field of Regulatory Information Management (RIM). We offer configurable off-the-shelf products as well as customized and integrated solutions. EXTEDO's enabling technology, the EXTEDOsuite, is unique in all that it covers within Regulatory Affairs including: eCTD submission management, pharmacovigilance or drug safety management and product registration planning & tracking. EXTEDO serves over 700 Life Sciences customers, both large and small, in 60 countries, including the EMA and over 25 regulatory authorities worldwide. The areas of Life Sciences in which Extedo operates are: pharmaceuticals, biotech and biopharma, generics, medical devices, healthcare and the public sector. We are still growing!
For our location in Wayne, PA (Greater Philadelphia area) we are actively seeking a
Publishing Consultant, Regulatory OperationsAs a Publishing Consultant your general purpose will be to assist the Regulatory Publishing department in the preparation, review and submission of various electronic applications to the Food and Drug Administration (FDA) and other regulatory bodies.
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.
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.
- Experience in the usage of modern collaboration tools like Office 365 is a plus.