New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

The purpose of the Global Labeling Therapeutic Area group is to drive labeling strategy and ensure high-quality and compliant labeling documents, which provide the safe and effective use of products for patients and healthcare providers globally. The Global Labeling Therapeutic Area group is accountable for developing labeling content and maintaining the target product labeling for developmental products, Core Labeling documents (e.g., CCDS, CCPPI, CCIFU) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU Labeling and other country’s local Labeling.  This position is 100% remote.

As part of the Global Labeling Therapeutic Area, and under the supervision of the Global Labeling Strategic Director, the GLL is responsible for: 

• Developing, maintaining and, implementing Core Labeling for assigned products in line with internal standards and guidelines 

• Developing, maintaining and, implementing US Labeling for assigned products in line with regulatory requirements and internal standards and guidelines 

• Assisting with developing and maintaining Local Labeling (EU and most of world) for assigned products  

• Providing labeling expertise and guidance to teams while ensuring compliance with applicable regulatory requirements 

• Serving as regulatory labeling point of contact on global Regulatory Affairs sub-teams to ensure delivery of labeling documents that meet quality and compliance standards and regulatory labeling requirements to support timely regulatory submissions for assigned products 

• Leading cross-functional teams to develop, review and approve Core and Local Labeling documents 

• Independently recommending strategies and labeling language for inclusion in Core or Local Labeling during labeling development or responses to Health Authority  

• Providing information to Global Labeling Compliance, as needed, to support internal and external (i.e., Regulatory Authority) requirements and support audits/inspections as a labeling subject matter expert 

• Evaluating risks associated with Core or Local Labeling content, developing mitigation strategies, and appropriately escalating issues to Global Labeling management and the Global Regulatory team 

• Proficiency in crucial labeling requirements worldwide 

• Contributing to the continuous improvements to the end-to-end labeling process, including labeling policies, procedures, quality, and system tools 

• Providing guidance and training to other Global Labeling Leads 

Competencies include:

• Ability to lead cross-functional labeling team (including senior management) exhibiting a combination of active listening skills and the confidence to address labeling issues, develop plans of action, drive consensus, and oversee completion of labeling project.  

• Independent ability to assimilate clinical and scientific information and present it concisely. Understanding of medical concepts and terminology. 

• Strong project management skills with the ability to handle multiple projects and prioritize work accordingly. 

• Proactive problem-solving ability with the ability to make appropriate. recommendations/decisions. 

• Tolerance for ambiguity and action-oriented. 

• Strong written and oral communication skills. 

• Attention to detail and accuracy. 

• Ability to influence and negotiate.