Senior Manager, Global Labeling Product Leader

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

Job Function :

Regulatory Affairs Group

Job Sub Function : Regulatory Affairs

Job Category : Professional

All Job Posting Locations :

Allschwil Basel-Country Switzerland

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 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-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 position is a hybrid role and will be located in Allschwil Switzerland.

The Senior Manager Global Labeling Product Leader is a leading expert individual contributor who is viewed as a valuable resource by peers and manages large projects or processes. This individual will develop methods for planning directing coordinating and controlling the regulatory affairs activities related to new and modified products worldwide in compliance with corporate policies and strategies. Ensure compliance with regulatory agency regulations and interpretations accounting for new and changing government regulations.

The Senior 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. 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 Bachelors degree in a scientific discipline is required. Advanced degree (Masters 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 application 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

Required Skills : 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

Required Experience :

Senior Manager

Key Skills

Time Management,Data Analytics,Analytical,Agile,Requirement Gathering,Strategic thinking,Visio,Communication,Problem Solving,Market Research,UML,Cross Functional Teams

Employment Type : Full-Time

Experience : years

Vacancy : 1