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Ass Director Global Labeling Prod Lead
View: 144
Update day: 14-04-2024
Location: Allschwil Basel-Landschaft BL
Category: Sales
Industry: Hospitals Health Care
Job type: Full-time
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Job content
Job DescriptionJanssen Research & Development, LLC, a member of Johnson & Johnson’s Family of Companies, is recruiting for an Associate Director Global Labeling Product Leader in the UK (High Wycombe); Netherlands (Leiden); Belgium (Beerse); Allschwil, Bern, Zug (Switzerland); or Remote work options may be considered, on a case-by-case basis and if approved by the Company.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 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 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 minimum of Bachelor’s degree (or equivalent) (required)
- A degree in a scientific field (required)
- An advanced degree (MS, Ph.D., MD or PharmD) (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
- 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
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Deadline: 29-05-2024
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