Manager, Global Labeling Product Leader

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium, Leiden, Netherlands, Warsaw, Masovian, Poland

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-065311

• United Kingdom - Requisition Number: R-066466

• Belgium, Netherlands, Poland - Requisition Number: R-066473

• Switzerland - Requisition Number: R-066484

• Canada - Requisition Number: R-072388

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 can be located in Beerse, Belgium; Leiden, Netherlands; or Warsaw, Poland.

The Manager, 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.

• 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.

• 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 4 years of relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc.) is required.

• A minimum of 3 years of Regulatory Affairs experience in product labeling/labeling regulations, or equivalent is preferred.

• An understanding of pharmaceutical drug development is required.

• Experience in discussing and communicating scientific concepts is required.

• Basic 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 participating in 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 drive a collaborative, customer-focused, learning culture is preferred.

#LI-Hybrid

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Writing, Coaching, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Process Improvements, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility