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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. We strive for smarter, less invasive treatments and personal solutions. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today, delivering the breakthroughs of tomorrow and profoundly impacting 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
Beerse, Antwerp, Belgium; Warsaw, Masovian, Poland
Job Description
About Innovative Medicine. Our expertise 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):
Available in these countries
United States – Requisition Number: R-042465
Belgium, Poland – Requisition Number: R-043330
United Kingdom – Requisition Number: R-044318
Switzerland – Requisition Number: R-044319
Brazil – Requisition Number: R-044320
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 Senior Manager, Global Labeling Product Leader. This hybrid role can be located in Beerse, Belgium or Warsaw, Poland.
Responsibilities
Lead the development, revision, review, agreement, and maintenance of primary labeling (Company Core Data Sheet, United States Package Insert, and associated patient labeling, European Union Product Information, and derived documents for EU and 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 implement the global labeling strategy, including understanding the competitors in the therapeutic area and their development plans and status.
Contribute to continuous improvement of the end‐to‐end labeling process.
Qualifications
Minimum of a Bachelor's degree in a scientific discipline required; advanced degree (Master's, PhD, PharmD) preferred.
Minimum of 8 years of professional work experience required.
Minimum of 6 years of direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent required.
Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) required.
Understanding of pharmaceutical drug development required.
Experience in discussing and communicating scientific concepts required.
Good understanding of worldwide regulatory guidelines and their application for labeling guidance required.
Experience leading project teams in a matrix environment required.
Experience leading continuous improvement projects required.
Experience working with document management systems required.
Experience effectively prioritizing and managing multiple products and projects simultaneously preferred.
Exceptional verbal and written communication skills required.
Strong organizational, negotiation, and partnering skills required.
Ability to work independently required.
Preferred: ability to manage compounds with a certain degree of complexity from a labeling perspective.
Preferred: ability to drive a collaborative, customer‐focused, learning culture.
Required Skills
None specified.
Preferred Skills
Analytical Reasoning
Business Writing
Fact‐Based Decision Making
Industry Analysis
Legal Support
Mentorship
Organizing
Product Licensing
Public Policies
Regulatory Affairs Management
Regulatory Compliance
Regulatory Development
Regulatory Environment
Risk Assessments
Risk Compliance
Strategic Thinking
Technical Credibility
Seniority Level
Not Applicable
Employment Type
Full‐time
Job Function
Product Management and Marketing
Industries
Pharmaceutical Manufacturing
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