Job Description
Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Manager, Global Labeling Product Leader. This hybrid role 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.
The responsibilities include:
* Lead the development, revision, review, agreement, and maintenance of primary labeling and associated documents 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 primary or derived labeling, or 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 understanding competitor plans and status and labeling aspects for development and target labeling.
* Contribute to the continuous improvement of the end-to-end labeling process.
Qualifications
* Minimum of a Bachelor’s degree in a scientific discipline is required. Advanced degree (Master’s, PhD, PharmD) in a scientific discipline is preferred.
* Minimum of 8 years of professional work experience is required.
* 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.
* Understanding of pharmaceutical drug development is required.
* Experience discussing and communicating scientific concepts is required.
* Good understanding of worldwide regulatory guidelines and their application 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 prioritizing and managing multiple products and projects simultaneously is preferred.
* Exceptional verbal and written communication skills.
* Strong organizational, negotiation, and partnering skills.
* Ability to work independently.
* 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
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
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
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