Associate Director, Global Labeling Product Leader

Johnson and Johnson; High Wycombe; Hybrid; GBP 75,000 - 100,000; Full time

Job summary

Johnson & Johnson is seeking an Associate Director, Global Labeling Product Leader in High Wycombe. In this hybrid role, you will lead development of labeling documentation for pharmaceutical products, ensuring compliance and quality while collaborating with internal and external stakeholders. Candidates with extensive regulatory experience and a strong educational background are encouraged to apply.

Qualifications

• A minimum of 8 years of professional work experience.
• 6 years of regulatory labeling content experience.
• Understanding of pharmaceutical drug development.

Responsibilities

• Lead the development and maintenance of primary labeling documents.
• Contribute to global labeling strategy and process improvement.
• Coordinate resolution of labeling issues with external partners.

Skills

Regulatory labeling content

Project management

Communication

Education

Bachelor’s degree in a scientific discipline

Master’s or PhD in a scientific discipline

Job description

Social network you want to login/join with:

Associate Director, Global Labeling Product Leader, High Wycombe

col-narrow-left

Client:

Johnson and Johnson

Location:

High Wycombe, United Kingdom

Job Category:

Other

-

EU work permit required:

Yes

col-narrow-right

Job Reference:

8204c04d79b8

Job Views:

8

Posted:

04.06.2025

Expiry Date:

19.07.2025

col-wide

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.comJob Function:Regulatory Affairs GroupJob Sub Function:Regulatory AffairsJob Category:ProfessionalAll Job Posting Locations:High Wycombe, Buckinghamshire, United KingdomJob Description:About Innovative MedicineOur 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-medicinePlease 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-009649Remember, 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 will be located in High Wycombe, United Kingdom.Remote work options may be considered on a case-by-case basis and if approved by the Company. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.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

Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit. Check our Blog for more information.

Bank or payment details should not be provided when applying for a job. Eurojobs.com is not responsible for any external website content. All applications should be made via the 'Apply now' button.

Created on 04/06/2025 by TN United Kingdom