Associate Director, Global Labeling Product Leader at Johnson & Johnson

High Wycombe, England, United Kingdom

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Expertise in global labeling strategy, including understanding of competitors in the therapeutic area, their development plans, status, and labeling aspects for new products
Ability to partner with Global Regulatory Leads (GRLs) and functional areas (clinical, safety, market access, commercial, medical affairs)
Knowledge of clinical study protocols, endpoints, Patient-Reported Outcomes (PROs), and label-as-driver approach
Strategic advice capability for local labeling in major markets
Ability to analyze competitor labeling, leverage guidance and trends, and identify risks/mitigations
Experience leading Health Authority (HA) labeling strategy discussions and contingency plans
Leadership in development, revision, review, agreement, and maintenance of target labeling, primary labeling (CCDS, USPI, patient labeling, EUPI), and derived documents
Leadership of cross-functional Labeling Working Group (LWG) and strategic discussions
Representation in Global Regulatory teams and cross-functional teams
Presentation skills at governance meetings (e.g., Labeling Committee)
Ability to provide advice on labeling content, processes, timelines, and scientific integrity, including coordination of resolutions

Responsibilities

Drive the global labeling strategy
Take a leadership role partnering with GRLs and functional areas to align labeling with Global Regulatory and Product Strategy
Lead target labeling development
Collaborate with functional areas on labeling input for clinical study protocols, ensuring alignment on endpoints and PROs with label-as-driver approach
Provide strategic labeling advice for local labeling in major markets
Analyze competitor labeling and trends to develop strategy and content, including risk identification and mitigation
Lead HA labeling strategy discussions and development of contingency plans/content
Lead development, revision, review, agreement, and maintenance of target/primary labeling and derived documents for assigned compounds
Lead cross-functional LWG and strategic labeling discussions for target/primary labeling
Represent global labeling in Global Regulatory teams and cross-functional teams
Present at governance meetings (e.g., Labeling Committee) for endorsement
Provide advice/guidance on labeling content, processes, timelines, scientific integrity, and coordinate resolution of labeling issues

Skills

Regulatory Affairs

Global Labeling

Product Leadership

Pharmaceutical R&D

Labeling Compliance

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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