Senior Manager, Global Labeling Product Leader at Johnson & Johnson

Allschwil, Basel-Landschaft, Switzerland

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, BiotechnologyIndustries

Requirements

Minimum of a Bachelor’s degree in a scientific discipline
Advanced degree (Master’s, PhD, PharmD) in a scientific discipline preferred
Minimum of 8 years of professional work experience
Minimum of 6 years of direct regulatory labeling content experience developing and writing labeling

Responsibilities

Lead the development, revision, review, agreement, and maintenance of primary labeling (Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, European Union Product Information (EUPI), and derived documents (labeling text for EU, US)) 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 the primary or derived labeling, or the supporting documentation
Ensure high quality and compliant labeling documents (may collaborate with external partners)
Contribute to and implement the global labeling strategy, including demonstrating an understanding of competitors in the therapeutic area and their development plans and status and knowledge of labeling aspects for the development of labeling and target labeling
Contribute to the continuous improvement of the end-to-end labeling process
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
Ensure compliance with regulatory agency regulations and interpretations accounting for new and changing government regulations

Skills

Regulatory Affairs

Global Labeling

Product Leadership

Pharmaceuticals

MedTech

R&D

Compliance

Labeling Strategy

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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