Associate Director, Global Labeling Product Leader at Johnson & Johnson

Beerse, Flanders, Belgium

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Advanced degree in a relevant scientific discipline (implied by role level and responsibilities in regulatory affairs for Innovative Medicine)
Extensive experience in global regulatory affairs, particularly in labeling strategy and development for pharmaceutical products
Deep knowledge of competitor labeling, therapeutic areas, development plans, and regulatory trends
Strong leadership and partnership skills to collaborate with Global Regulatory Leads (GRLs), clinical, safety, market access, commercial, and medical affairs teams
Expertise in Health Authority interactions, labeling guidance, and major market regulations (e.g., USPI, EUPI, CCDS)
Ability to lead cross-functional teams, governance meetings (e.g., Labeling Committee, Labeling Working Group), and strategic discussions
Hybrid work capability in Beerse, Belgium or Warsaw, Poland

Responsibilities

Drive the global labeling strategy, including understanding competitors in the therapeutic area, their development plans, status, and labeling aspects for new products
Take a leadership role and partner with Global Regulatory Leads (GRLs) and other functional areas (clinical, safety, market access, commercial, medical affairs) to align global labeling strategy with Global Regulatory and Product Strategy
Lead target labeling development
Collaborate with functional areas to provide labeling input for clinical study protocols, ensuring 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 competitor labeling, leverage labeling guidance and trends to develop strategy and content, including risk identification, assessment, and mitigation
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 for target and primary labeling
Represent global labeling in Global Regulatory teams and other cross-functional teams
Present at governance meetings, such as Labeling Committee, to seek endorsement of labeling
Provide advice and guidance on labeling content, processes, timelines, and scientific integrity
Coordinate the resolution of any labeling-related issues

Skills

Regulatory Affairs

Global Labeling

Product Leadership

Pharmaceutical R&D

Compliance

Innovative Medicine

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters

1886Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.

Former J&J executives joining other firms could lead to increased competition.

Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.

The company invests heavily in R&D for innovative medical solutions and products.

J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.

The rise of personalized medicine offers J&J opportunities in targeted therapies.

Increased focus on digital health solutions presents expansion opportunities for J&J.

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