Senior Specialist, Global Labeling Operations

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Product Submissions and Registration

Job Category:

Professional

All Job Posting Locations:

Warsaw, Masovian, Poland

Job Description:

Johnson & Johnson Innovative Medicine is recruiting for a Global Labeling Operations Senior Specialist in Warsaw. Poland.

At Johnson & Johnson Innovative Medicine, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it.

Our company thrives on a diverse company culture, celebrating the uniqueness of our employees and is committed to inclusion. Janssen is proud to be an equal opportunity employer.

Our culture is interconnected by the shared values of Our Credo. It is a culture that celebrates diversity and diverse perspectives, and helps its employees achieve an effective balance between work and home life and supports their efforts to have a positive impact on their communities.

Key Responsibilities:

• Complete, correct, and timely entry of content and data into resident systems and trackers in alignment with strategy agreed upon with Global Labeling staff 
• Track key labeling deliverables and milestones using tracking tools, document repositories, and other related systems and technologies
• Support labeling document development, refinement, and finalization under direction of Global Labeling staff
• Provide submissions support related to labeling and labeling-related inputs
• Engage in process improvement activities and initiatives  

Qualifications

Education:

• A minimum of bachelor’s degree or equivalent (required)

Experience and Skills:

Required:

• Minimum 4 years' experience supporting labeling development, implementation, or operations in the pharmaceutical industry, or equivalent experience supporting Regulatory processes associated with labeling
• An understanding of the pharmaceutical development process
• Knowledge of labeling processes and systems
• Strong verbal and written communication, organizational, and collaboration skills

Preferred:

• Experience working in Veeva Regulatory Management system
• Experience monitoring deliverables and milestones for labeling or other Regulatory functions
• Planning, scheduling, facilitating meetings across stakeholder groups
• Experience working with dashboards and metrics (e.g., Tableau) and Microsoft Teams tools and apps