Johnson & Johnson · 17 hours ago
Associate Director, Global Labeling Product Leader
Raritan, New Jersey, United States of America
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$137K/yr - $236K/yr
8+ years expJohnson & Johnson is a leader in healthcare innovation, dedicated to developing treatments and pioneering solutions for complex diseases. The Associate Director, Global Labeling Product Leader will drive the global labeling strategy, collaborate with various teams to ensure alignment with regulatory requirements, and lead the development of labeling content for pharmaceutical products.
Hospital & Health Care
Responsibilities
Drive the global labeling strategy, including demonstrating an understanding of competitors in the therapeutic area, their development plans and status and knowledge of labeling aspects for labeling development and target labeling for new products
Take a leadership role and partner with Global Regulatory Leads (GRLs) and other functional area partners (clinical, safety, market access, commercial, medical affairs) to ensure the global labeling strategy aligns with the Global Regulatory and Product Strategy for assigned products
Lead target labeling development
Collaborate with functional areas to provide labeling input relevant to clinical study protocols and ensure alignment on endpoints and Patient-Reported Outcomes (PROs), with a label-as-driver approach
Provide strategic labeling advice for local labeling in major markets
Analyze relevant competitor labeling, leverage labeling guidance and trends to develop labeling strategy and content, including risk and mitigation identification and assessment
Lead Health Authority (HA) labeling strategy discussions and development of contingency labeling plans and content
Lead the development, revision, review, agreement, and maintenance of target labeling, primary labeling (Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, European Union Product Information (EUPI), and derived documents) for assigned compounds
Lead cross-functional Labeling Working Group (LWG) and strategic labeling discussions leading to development of target and primary labeling
Represent global labeling in Global Regulatory teams and other cross-functional teams, as appropriate
Present at governance meetings, such as Labeling Committee, to seek endorsement of labeling
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 the continuous improvement of the end-to-end labeling process
Support global labeling inspections and audits for assigned products, as applicable
This role may collaborate with external partners
Qualification
Required
A minimum of a Bachelor's degree in a scientific discipline is required
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
Must have exceptional verbal and written communication skills
Must have strong organizational, negotiation, and partnering skills
Must have the ability to work independently
Preferred
Advanced degree (Master's PhD, PharmD) in a scientific discipline is preferred
Direct experience with target labeling development or New Molecular Entity (NME) submissions is preferred
Experience effectively/appropriately prioritizing and managing multiple products and projects simultaneously is preferred
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
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
Holiday pay, including Floating Holidays - up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Company
Johnson & Johnson
At Johnson & Johnson, we believe health is everything.
10001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (48)
2024 (56)
2023 (58)
2022 (59)
2021 (44)
2020 (27)
Funding
Current Stage
Late StageLeadership Team
Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
Joaquin Duato
Chairman of the Board and Chief Executive Officer
Recent News
2025-10-07
2025-10-07
Company data provided by crunchbase