Senior 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 https://www.jnj.com

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

São Paulo, Brazil

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-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 Sao Paulo, Brazil.

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 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 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