Manager, Global Labeling Product Leader

Johnson & Johnson Co.; Województwo mazowieckie; In loco; PLN 358.000 - 618.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Descrizione del lavoro

Johnson & Johnson is seeking a Manager, Global Labeling Product Leader to drive strategic labeling activities across Beerse, Belgium or Warsaw, Poland. The role oversees CCDS, USPI, EU Product Information, and derived labeling, shaping content, timelines, and scientific integrity.

We value strong communication, cross-functional collaboration, and experience leading labeling projects in a matrix environment.

Competenze

• Bachelor’s degree in a scientific discipline required.
• 4 years of relevant pharma industry experience required.
• 3 years of Regulatory Affairs with labeling experience preferred.
• Understanding of worldwide regulatory guidelines required.
• Experience leading project teams in a matrix environment required.
• Strong written and verbal communication and negotiation skills required.
• Experience with document management systems required.
• Ability to prioritize multiple products and projects.

Mansioni

• Lead development, revision, review, agreement, and maintenance of primary labeling documents and derived documents for assigned compounds.
• Provide guidance on labeling content, processes, timelines, and scientific integrity; resolve labeling issues.
• Contribute to the global labeling strategy and understand competitive landscape.
• Assist in continuous improvement of the end-to-end labeling process.

Conoscenze

Regulatory Affairs

Labeling

Project leadership

Scientific communication

Cross-functional teamwork

Formazione

Bachelor’s degree in a scientific discipline

Advanced degree (MS, PhD, MD or PharmD) preferred

Strumenti

Document management systems

Descrizione del lavoro

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 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, Warsaw, Masovian, Poland

Job Description

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-103361

Belgium and Poland- Requisition Number: R-106224

Switzerland - Requisition Number: R-106231

United Kingdom- Requisition Number: R-106250

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

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

We are searching for the best talent for our Manager, Global Labeling Product Leader to be based in Beerse, Belgium or Warsaw, Poland.

Purpose:

Global Labeling (GL) is a function within Global Regulatory Affairs accountable for the strategic development and lifecycle management of product labeling across therapeutic areas, established products, regions, and affiliates.

The Scope Of Global Labeling Covers The End-to-end Labeling Process Throughout The Product’s Lifecycle —from Target Labeling Through The Company Core Data Sheet (CCDS)

• Primary labeling documents (Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, European Union Product Information (EUPI))
• Derived labeling documents

Our Vision and Mission articulate Global Labeling’s commitment to providing high‑quality, compliant, and timely labeling that supports our stakeholders and patients worldwide.

You Will Be Responsible For

• Leading 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.
• Making 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.
• Contributing 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.
• Contributing to the continuous improvement of the end-to-end labeling process.

Qualifications / Requirements

• A minimum of Bachelor’s degree in a scientific discipline is required. An advanced degree (MS, PhD, MD or PharmD) is preferred.
• A minimum of 4 years of relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) is required.
• A minimum of 3 years of Regulatory Affairs with 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 within a matrix environment, combined with the ability to work largely independently with limited supervision is required.
• A demonstrated proactive approach, experience participating in continuous improvement projects, and exceptional verbal and written communication, organizational, negotiation and partnering skills is required.
• Experience working in document management systems is required.
• A successful track record of effectively/appropriately prioritizing and managing multiple products and projects simultaneously is preferred.
• Demonstrated ability to drive a collaborative, customer-focused, learning culture is preferred.

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

The anticipated pay range for this position, in the primary posting location, is:

€82,000.00 - €141,450.00

The anticipated pay ranges for additional locations are:

Poland – The anticipated base pay range for this position is 205,000 – 354,200

Benefits

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

• This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.