Manager, Global Labeling Product Leader - 2406208837W

Description

Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Global Labeling Product Leader in Raritan, NJ; Titusville, NJ; Horsham, PA; Toronto, Ontario (CA); UK (High Wycombe); Netherlands (Leiden); Belgium (Beerse); Allschwil, Bern, Zug (Switzerland)

At the Janssen Pharmaceutical Companies of Johnson & Johnson, 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. Learn more at www.janssen.com (file:///C:/Users/jamie yacco/AppData/Local/Microsoft/Windows/Temporary Internet Files/Content.Outlook/JHNHJA6O/www.janssen.com) and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

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:

• 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.

• Contribute to and participate in 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.

Qualifications

Education

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

• A degree in scientific discipline (required)

• An advanced degree (MS, PhD, MD or PharmD) (preferred)

Required Skills:

• Minimum of 4 years of relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance)

• An understanding of pharmaceutical drug development

• Experience in discussing and communicating scientific concepts

• Basic 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 largely independently with limited supervision

• A demonstrated proactive approach, experience participating in continuous improvement projects, and exceptional verbal and written communication, organizational, negotiation and partnering skills

• Experience working in document management systems

Preferred Skills:

• 3 years of Regulatory Affairs with experience in product labeling/labeling regulations, or equivalent

• A successful track record of effectively/appropriately prioritizing and managing multiple products and projects simultaneously

• An understanding of pharmaceutical drug development

• Demonstrated ability to drive a collaborative, customer-focused, learning culture

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long-term incentive, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.

For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

Primary Location Europe/Middle East/Africa-Belgium-Antwerp-Beerse

Other Locations NA-US-Pennsylvania-Horsham, Europe/Middle East/Africa-Switzerland-Berne-Bern, NA-US-New Jersey-Titusville, Europe/Middle East/Africa-Switzerland-Zug-Zug, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, NA-CA-Ontario-Toronto, NA-US-New Jersey-Raritan, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Switzerland-Basel-Country-Allschwil

Organization Janssen Cilag Ltd. (7360)

Job Function Regulatory Affairs

Req ID: 2406208837W