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
Junior Publishing Consultant, Regulatory Operations
As a Junior 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.
- Proficient with a Windows environment, Office 365 (Sharepoint, Outlook, Word, Excel) and Adobe Acrobat. Ability to implement new computer software with minimal supervision.
- Preferred but not required: experience with SQL or XML.
- Very good organizational and prioritization skills.
- Great attention to detail.
- Strong oral and written communication skills.