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- Tasks: Lead the development and maintenance of product labeling for innovative medicines.
- Company: Join Johnson & Johnson, a leader in healthcare innovation dedicated to improving lives.
- Benefits: Enjoy a hybrid work model and opportunities for professional growth.
- Why this job: Be part of a team that saves lives and shapes the future of healthcare.
- Qualifications: Bachelor's degree in a scientific field; 4+ years in the pharmaceutical industry required.
- Other info: This role is available across multiple countries; apply to your preferred location.
The predicted salary is between 43200 - 72000 £ per year.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
High Wycombe, Buckinghamshire, United Kingdom
Job Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
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United States – Requisition Number: R-020573
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Belgium – Requisition Number: R-021550
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United Kingdom – Requisition Number R-021551
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Switzerland – Requisition Number: R-021552
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Johnson & Johnson Innovative Medicine R&D is recruiting for a Manager, Global Labeling Product Leader. This position is a hybrid role and will be located in High Wycombe, United Kingdom.
The Manager, Global Labeling Product Leader will be responsible for the following:
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Lead the development, revision, review, agreement, and maintenance of primary labeling (Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, European Union Product Information (EUPI), and derived documents (labeling text for EU, US)) for assigned compounds.
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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.
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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.
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Contribute to the continuous improvement of the end-to-end labeling process.
Qualifications:
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A minimum of a Bachelor’s degree in a scientific discipline is required. Advanced degree (Master’s PhD, PharmD) in a scientific discipline is preferred.
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A minimum of 4 years of relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc.) is required.
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A minimum of 3 years of Regulatory Affairs experience in product labeling/labeling regulations, or equivalent is preferred.
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An understanding of pharmaceutical drug development is required.
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Experience in discussing and communicating scientific concepts is required.
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Basic understanding of worldwide regulatory guidelines and their applications for guidance for labeling is required.
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Experience leading project teams in a matrix environment is required.
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Experience participating in continuous improvement projects is required.
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Experience working with document management systems is required.
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Experience effectively/appropriately prioritizing and managing multiple products and projects simultaneously is preferred.
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Must have exceptional verbal and written communication skills.
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Must have strong organizational, negotiation, and partnering skills.
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Must have the ability to work independently.
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The ability to drive a collaborative, customer-focused, learning culture is preferred.
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Manager, Global Labeling Product Leader employer: Johnson & Johnson
Contact Detail:
Johnson & Johnson Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Manager, Global Labeling Product Leader
✨Tip Number 1
Familiarise yourself with the latest trends and regulations in global labeling within the pharmaceutical industry. Understanding the nuances of labelling requirements across different regions will give you an edge during discussions and interviews.
✨Tip Number 2
Network with professionals in Regulatory Affairs, especially those who have experience in product labeling. Attend industry conferences or webinars to connect with potential colleagues at Johnson & Johnson and gain insights into their work culture.
✨Tip Number 3
Prepare to discuss specific examples of how you've contributed to continuous improvement projects in your previous roles. Highlighting your ability to enhance processes will resonate well with the hiring team.
✨Tip Number 4
Showcase your communication skills by being clear and concise in your interactions. Whether it's during networking or interviews, demonstrating your ability to convey complex scientific concepts simply will be crucial for this role.
We think you need these skills to ace Manager, Global Labeling Product Leader
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the Manager, Global Labeling Product Leader position at Johnson & Johnson. Understand the key responsibilities and qualifications required, as this will help you tailor your application.
Tailor Your CV: Customise your CV to highlight relevant experience in regulatory affairs, particularly in product labeling. Emphasise your achievements and skills that align with the requirements mentioned in the job description, such as your understanding of pharmaceutical drug development and experience in leading project teams.
Craft a Compelling Cover Letter: Write a cover letter that not only introduces yourself but also explains why you are a great fit for the role. Mention specific experiences that demonstrate your expertise in labeling regulations and your ability to contribute to the global labeling strategy.
Proofread Your Application: Before submitting your application, carefully proofread your CV and cover letter. Check for any spelling or grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail, which is crucial for the role.
How to prepare for a job interview at Johnson & Johnson
✨Understand the Role and Responsibilities
Before the interview, make sure you thoroughly understand the job description and responsibilities of the Manager, Global Labeling Product Leader. Familiarise yourself with key terms like CCDS, USPI, and EUPI, as well as the regulatory landscape in which Johnson & Johnson operates.
✨Showcase Your Regulatory Affairs Experience
Highlight your relevant experience in Regulatory Affairs, especially in product labeling and regulations. Be prepared to discuss specific projects where you led teams or contributed to continuous improvement initiatives, demonstrating your ability to manage multiple products and projects.
✨Communicate Scientific Concepts Clearly
Since the role requires discussing and communicating scientific concepts, practice explaining complex ideas in simple terms. This will showcase your communication skills and your ability to convey important information effectively to various stakeholders.
✨Demonstrate a Collaborative Mindset
Johnson & Johnson values a collaborative and customer-focused culture. Prepare examples from your past experiences that illustrate how you've successfully worked in a team environment, resolved conflicts, or partnered with others to achieve common goals.
