Siemens Careers

Director, Content Development Product Labeling Immunoassay (IA)

Tarrytown, New York
Engineering

Apply
English (US)

Job Description

Division: Siemens Healthineers
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%

Division Description:

siemens

Job Description:

The Head, Content Development Product Labeling Immunoassay  (IA) will provide strategic leadership for all labeling and user content of in vitro diagnostic products within the CH/SP assays for global markets; accountable for content and visual design of product labeling, product packaging, instructions for use, and user assistance communication.
 
Plans and directs practices and resources to support content development, review, localization and delivery activities supporting the 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.
 
Accountable for staff implementation of tools and processes needed to support group practices. Ensures all projects, initiatives, and processes are in conformance with organization's established policies and objectives
 
Reports to the Head of Content Development and Product Labeling.
 
Position Summary
 
  • 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.
 
Responsibilities
 
  • 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 Knowledge/Skills, Education, and Experience
 
  • 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


#LI-LP1



Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.