Associate Director, Global Labeling Product Leader

TN United Kingdom; High Wycombe; Hybrid; GBP 60,000 - 100,000; Full time

Job summary

An established industry player is seeking an Associate Director, Global Labeling Product Leader to join their innovative team in High Wycombe. This hybrid role involves leading the development and maintenance of critical labeling documents for pharmaceutical products, ensuring compliance and scientific integrity. With a focus on collaboration and continuous improvement, you will play a pivotal role in shaping the global labeling strategy while guiding teams through complex regulatory landscapes. This position offers a unique opportunity to impact patient care by ensuring accurate and effective communication of labeling information.

Qualifications

• 8+ years of experience in regulatory labeling content development.
• Strong understanding of worldwide regulatory guidelines.
• Exceptional verbal and written communication skills.

Responsibilities

• Lead development and maintenance of primary labeling for pharmaceutical products.
• Contribute to global labeling strategy and continuous improvement processes.
• Coordinate resolution of labeling issues with external partners.

Skills

Regulatory Affairs

Labeling Content Development

Project Management

Communication Skills

Scientific Understanding

Education

Bachelor's Degree in a Scientific Discipline

Master's Degree or PhD in a Scientific Discipline

Tools

Document Management Systems

Job description

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Associate Director, Global Labeling Product Leader, High Wycombe

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Client:

Johnson and Johnson

Location:

High Wycombe, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

8204c04d79b8

Job Views:

4

Posted:

05.05.2025

Expiry Date:

19.06.2025

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Job Description:

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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): * United States - Requisition Number: R-008331 * Canada - Requisition Number: R-009630 * Belgium - Requisition Number: R-009644 * United Kingdom - Requisition Number R-009647 * Switzerland - Requisition Number: R-009649 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 an Associate Director, Global Labeling Product Leader. This position is a hybrid role and can be located in High Wycombe, United Kingdom. The Associate Director, Global Labeling Product Leader will be responsible for the following: * 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. * 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. Qualifications: * 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. * A minimum of 8 years of professional work experience is required. * A minimum of 6 years of direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent is required. * Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc.) is required. * An understanding of pharmaceutical drug development is required. * Experience in discussing and communicating scientific concepts is required. * Good understanding of worldwide regulatory guidelines and their applications for guidance for labeling is required. * Experience leading project teams in a matrix environment is required. * Experience leading continuous improvement projects is required. * Experience working with document management systems is required. * Experience effectively/appropriately prioritizing and managing multiple products and projects simultaneously is preferred. * Must have exceptional verbal and written communication skills. * Must have strong organizational, negotiation, and partnering skills. * Must have the ability to work independently. * The ability to manage compounds with a certain degree of complexity from a labeling perspective is preferred. * The ability to drive a collaborative, customer-focused, learning culture is preferred. #LI-Hybrid