Documentation Specialist
Novartis - Lincoln, NE

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Job Purpose
Provide high quality drug substance/drug product CMC documentation to support complex global regulatory submissions for GPD projects and initiatives. Provide high quality internal documentation to support GPD project activities.

Major Accountabilities
• Write high-quality CMC documentation during development and product registration, respecting agreed CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
• Assist with providing information for responses to health authority questions during development and registration.
• Identify the required documentation for submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
• Partner closely with GRA CMC associate responsible for project for review and approval of CMC documents.
• Keep knowledge up to date with regard to guidelines and regulatory as well as technical trends.
• Write high-quality internal analytical documentation for GPD in conjunction with technical experts. Write product monograph and raw material monographs. Assist with writing of analytical method validation documents including protocols and reports. Assist with writing of analytical instrumentation documents, including qualification and requalification protocols and reports.
• Assist with review and approval processes of pharmaceutical development documentation for developmental projects.
• Assure timely delivery of all documents to customers.
• Applies systems (EDMS, Novstyle, Access, SharePoint) and procedures necessary to maintain proper records and documentation management
• May contribute to special assigned activities and projects within the team or on cross-functional assignments & projects.

Key Performance Indicators

 High quality and timely submissions and approvals of new products according to business priorities
 Project Milestone and launch readiness
 Quality and compliance metrics for regulatory affairs
 Productivity and process efficiency metrics.

Minimum requirements
Minimum BA, BS, preferred MA, MS, PhD, or equivalent 2(Specialist) to 3 - 5 (Senior Specialist) and 5+ (Manager) years in pharmaceutical industry.

Technical writing and regulatory experience preferred.

About this company
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Novartis AG, incorporated on February 29, 1996, is a Switzerland-based holding that, through its subsidiaries, is engaged in the research,...