The Head, Content Development and Product Labeling will provide leadership, innovation and technical expertise for the creation, maintenance and implementation of customer-facing technical documentation, product labeling and user assistance content of in vitro diagnostic products to meet company objectives and country-specific regulatory requirements.
Scope of responsibilities includes development of instrument and software labeling, packaging content and instructions for use; and component labeling, packaging content, product inserts and instructions for use for assays and consumables. Provides strategic and operational regulatory labeling input to labeling content, submission, production, and implementation worldwide.
Plans and directs practices and resources to support labeling design, content development, review, localization and delivery activities supporting the full diagnostic product lifecycle, providing development strategies, resource planning and budgeting, and tracking / reporting status. Leads and directs the work of managers and developers, including external business partners.
Acts as primary interface with LD leadership in all business initiatives affecting product labeling and customer documentation. Acts as product labeling subject matter expert to Siemens Healthineers business initiatives.
Accountable for selection and implementation of tools and processes needed to support group practices. Drives practice innovation to continuously improve quality and efficiency of department. Ensures all projects, initiatives, and processes are in conformance with organization's established policies and objectives.
- Proven skill for maintaining excellent collaborative relationships with R+D, Marketing & Sales, Regulatory/Quality, Supply Chain Management and other business functions.
- Experience in developing, controlling and maintaining product labeling content and design standards.
- Ability to facilitate collaboration with design and usability specialists to drive excellence in content and design usability.
- Ability to influence and lead a diverse group of Subject Matter Experts from a variety of disciplines and facilitate discussions and decision making.
- Strong organization skills and ability to network and coordinate activities across all levels of the company to reach resolution on labeling topics.
- Maintain awareness of global regulatory environment and assess impact of changes on business and product labeling activities
- Experience leading high to medium complex projects
Reports to the Head, R&D Assay Development
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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