Ass Director Global Labeling Prod Lead

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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.

Job QualificationsQualificationsEducation:

• 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)

Experience and Skills:Required

• 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

Preferred:

• 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

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 ground breaking 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 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, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request an accommodation.Primary LocationEurope/Middle East/Africa-United Kingdom-England-High WycombeOther LocationsEurope/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Switzerland-Basel-Country-Allschwil, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-Poland-Mazowieckie-WarsawOrganizationJanssen Cilag Ltd. (7360)Job FunctionRegulatory Affairs