Director, Content Development Product Labeling Immunoassay (IA)
Business Unit: Laboratory Diagnostics
Requisition Number: 227402
Primary Location: United States-New York-Tarrytown
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 10%
- Functional Manager for Content Development staff for IA
Accountable for the performance, resources plans, decision-making and overall team performance of Content Development staff for IA, e.g. IVDR, Complaint handling and Core team performance.
Reports to the Head of Content Development and Product Labeling, ideally sits in Tarrytown, NY, closer to the Business Heads for the IA business.
- Functional manager for IA staff for Assay Content Development
- Product Labeling representative at the PHT/PLM boards as well as other functional meetings involving Product Labeling.
- Drive process excellence and content development practice within the IA functional area for Assays within UID
- Facilitate decision-making process for Content Development in terms of technology, process excellence, design quality and product labeling lifecycle
- Ensures Content Development for IA are compliant with Industry, Agency and Siemens Healthineer standards and laws.
Acts as primary interface with Product Lifecycle Management (PLM), PHT and PDP teams in all business initiatives affecting product labeling and customer documentation for IA.
- Responsible for maintaining excellent collaborative relationships with R+D, Product Marketing, Regulatory/Quality and other business functions.
- Collaborates with usability specialists and customer facing functions to drive excellence in content and design usability.
- Required B.A., preferable focus in Science, Technology or Regulatory
- Required 8+ years in LD, Life Sciences, Packaging or R&D
- 10% travel
- Required knowledge of Labeling, Regulatory, Packaging and LD Business