Associate Director, Global Labeling Product Leader

Join to apply for the Associate Director, Global Labeling Product Leader role at Johnson & Johnson Innovative Medicine .

The role is a hybrid position and can be located in Raritan, NJ; Titusville, NJ; or Horsham, PA.

Overview

Johnson & Johnson Innovative Medicine focuses on delivering breakthroughs across Innovative Medicine and MedTech to improve health. Visionaries work on teams that develop medicines of tomorrow and champion patients every step of the way.

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. Learn more at

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).

Locations

• United States - Requisition Number: R-
• Belgium, Poland - Requisition Number: R-
• United Kingdom - Requisition Number: R-
• Switzerland - Requisition Number: R-

Note: applications may be considered as a single submission across requisition numbers.

Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director, Global Labeling Product Leader. This position is a hybrid role and can be located in Raritan, NJ; Titusville, NJ; or Horsham, PA.

Responsibilities

• Drive the global labeling strategy, including understanding competitors in the therapeutic area, their development plans, and labeling aspects for labeling development and target labeling for new products.
• Lead 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 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), US 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 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.

Qualifications

• Bachelor's degree in a scientific discipline is required; advanced degree (Master's, PhD, PharmD) is preferred.
• Minimum of 8 years of professional work experience.
• Minimum of 6 years of direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent.
• Direct experience with target labeling development or New Molecular Entity (NME) submissions is preferred.
• Relevant experience in the pharmaceutical industry (Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc.) is required.
• Understanding of pharmaceutical drug development is required.
• Experience in discussing and communicating scientific concepts is required.
• Strong understanding of worldwide regulatory guidelines and their application for labeling is required.
• Experience leading project teams in a matrix environment and leading continuous improvement projects is required.
• Experience working with document management systems is required.
• Ability to prioritize and manage multiple products and projects simultaneously is preferred.
• Exceptional verbal and written communication skills; strong organizational, negotiation, and partnering skills; ability to work independently.
• Ability to manage compounds with a degree of complexity from a labeling perspective is preferred.
• Ability to drive a collaborative, customer-focused, learning culture is preferred.

Compensation and Benefits

• Base pay range for U.S. locations: $137,000 to $235,750.
• Eligible for an annual performance bonus as per applicable plan; bonus is discretionary.
• Company-sponsored benefits include medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Consolidated retirement plan (pension) and 401(k) savings plan.

Time Off

• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for residents of Washington - up to 56 hours
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

Additional information: The compensation and benefits information applies to U.S. hires; for non-U.S. hires, compensation and benefits will align with local practices. The posting may close on September 11, 2025, but may be extended. Johnson & Johnson is an Equal Opportunity Employer and participates in the federal contractor VEVRAA and Rehabilitation Act accommodations. For disability accommodations, contact