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.
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)), and derived documents (labeling text for EU, US) for assigned compounds.
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.
Bachelor's degree (or equivalent) in a scientific discipline required. An advanced degree (MS, PhD, MD or PharmD) in a scientific discipline preferred.
Experience and Skills:
Minimum of 8 years 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.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
The anticipated base pay range for this position in the San Francisco Bay Area, CA is $166,00 to $267,145.
The anticipated base pay range for this position in all other US locations is $135,000 - $232,300.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
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
Additional information can be found through the link below.
For additional general information on Company benefits, please go to: - https://https://www.careers.jnj.com/employee-benefits
This job posting is anticipated to close on 2/9/24. The Company may however extend this time-period, in which case the posting will remain available on https://https://www.careers.jnj.com to accept additional applications.
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.