Reports To: Senior Manager, Regulatory
The Regulatory Publisher will support a variety of document publishing, proofing and archiving needs for the Regulatory Operations Department. The position reports to the Senior Manager, Regulatory. Please Note: THIS IS NOT A DESIGN OR TECHNICAL WRITING POSITION.
Essential functions include but are not limited to the following:
Submissions Publishing
- Support technical publishing needs as required within the company
- Scan, convert, and format FDA-directed documents using internal publishing templates, specifications, and style guide
- Create Hypertext links and bookmarks of Acrobat .pdf files
- Perform format proofing
- Maintain various regulatory files, databases/logs, and controlled documents
- Assume responsibility for compilation of routine regulatory submissions
Documentation Coordination
- Assist with approval process and workflow of documents
- Issue and archive documents
- Assist in version control and tracking of documents in development
- Provide support with compliance activities
- Strong technical, template-based desktop publishing experience in MS Word desired as well as experience using stylesheets, cross-references, generated lists, pdf conversion, Adobe Acrobat, Photoshop, and common Scanning/OCR functions
- Experience working with and navigating large volumes of technical documents
- High attention to detail and accuracy
- Desire to learn new applications and tasks
- Familiarity with ISI Toolbox, Impress Pro and/or electronic publishing tools in an FDA-regulated publishing environment desirable
- Strong organizational, communication and interpersonal skills
- Ability to prioritize and multi-task
Human Resources
Medivation, Inc.
201 Spear Street
3rd Floor
San Francisco, CA 94105
hr@medivation.com
