Associate Director, Global Labeling Product Leader
Johnson & Johnson
- Raritan, NJ
- Permanent
- Full-time
- Lead the development, revision, review, agreement, and maintenance of primary labeling (the Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, EU Product Information (EUPI)).
- Make recommendations and provide advice and guidance about labeling content, processes, timelines, and scientific integrity. Coordinate the resolution of any labeling issues with potential impact on the primary or derived labeling, or the supporting documentation. Ensure high-quality and compliant labeling documents. This role may collaborate with external partners.
- Contribute to and implement the global labeling strategy, including demonstrating an understanding of competitors in the therapeutic area and their development plans and status and knowledge of labeling aspects for the development of labeling and target labeling.
- Contribute to the continuous improvement of the end-to-end labeling process.
- A bachelor's degree (or equivalent) in a scientific discipline is required. An advanced degree (MS, PhD, MD, or PharmD) in a scientific discipline is preferred.
- Minimum of 8 years of professional experience.
- Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) including at least 6 years of direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent experience.
- An understanding of pharmaceutical drug development.
- Experience in discussing and communicating scientific concepts.
- Good understanding of worldwide regulatory guidelines and their applications for guidance for labeling.
- Experience leading project teams within a matrix environment, combined with the ability to work independently.
- A demonstrated proactive approach, experience leading continuous improvement projects, and exceptional verbal and written communication, organizational, negotiation, and partnering skills.
- Experience working in document management systems.
- Ability to manage compounds with a certain degree of complexity from a labeling perspective.
- A successful track record of effectively/appropriately prioritizing and managing multiple products and projects simultaneously.
- Demonstrated ability to drive a collaborative, customer-focused, learning culture.
- Vacation - up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year