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Careers >Technical Publishing Specialist

Proteolix is seeking a specialist who will be responsible for the publication of regulatory documents according to regulatory authority specifications and department standards for paper and electronic submissions.  This person will assist in the development of electronic submissions standards and tools.  He/she will also coordinate the review and revision of all regulatory documents for submission to regulatory agencies.

Roles and Responsibilities:

This person will integrate data from various electronic or paper sources into either electronic or paper submissions using format and style essential for regulatory compliance with established operating procedures, and current medical and technical writing standards.
He/she will collaborate effectively with Proteolix and contract team members to publish, copy, assemble, quality check, and publish required documents.  In addition, he/she will continue to develop expertise through participation in both internal and external technical training.  Other responsibilities include:

• Demonstrate proficiency in required software.
• Provide word processing, advanced formatting, and publishing assistance to Regulatory and Clinical personnel.
• Create and maintain templates for regulatory submissions.
• Assist in maintenance of Regulatory archives.
• Assist with the incorporation of document comments from multiple reviewers including text, graphs, charts, tables and statistical analysis.
• Review documents for format compliance to current style guidelines and correct deficiencies within timeline.
• Assist with the coordination of regulatory document routing, revision tracking, proof-reading, and document approvals.
• May perform additional tasks and duties as assigned.

Please send all inquiries to careers@proteolix.com. No agencies please.