Cell Therapy Safety Analysis Lead

Johnson & Johnson Co.; Titusville (NJ); Presencial; USD 120.000 - 207.000; Tempo integral

Resumo da vaga

Johnson & Johnson is seeking a Manager, Safety Analysis Scientist – Cell Therapy based in Raritan, NJ, Titusville, NJ, or Horsham, PA. You will partner with MSO and SMT to prepare scientific safety analyses and evaluate data for regulatory decisions in both marketed and development-stage products.

The role requires at least six years of experience, a health-related bachelor’s, and excellent communication. You will mentor SASs, lead data reviews, and support audits and health authority

Qualificações

• Bachelor's degree in healthcare-related field or biomedical science required.
• Advanced degree is preferred.

Responsabilidades

• Lead safety evaluations with data retrieval, analysis, and reporting.
• Ensure high-quality safety evaluations and reports with minimal-to-moderate revisions.
• Provide support to Associate Director SASs for novel projects.
• Provide input and review of key regulatory or clinical documents as appropriate.
• Demonstrate leadership in the SMT and support the MSO.
• Support SMT activities (e.g., preparing and presenting data, meeting minutes).
• Lead proactive safety data reviews and form a safety position across GMS.
• Provide support for Health Authority interactions regarding safety and risk management.
• Mentor other SASs and contribute to cross-functional initiatives.
• Assist in the creation, review and implementation of controlled documents and audits.

Conhecimentos

Leadership

Data analysis

Medical data analysis

Communication

Stakeholder management

Matrix environment

MS Office

Project planning

Cross-functional collaboration

Formação

Bachelor's degree in healthcare or biomedical science

Advanced degree preferred

Descrição da vaga

Johnson & Johnson is seeking a Manager, Safety Analysis Scientist – Cell Therapy based in Raritan, NJ, Titusville, NJ, or Horsham, PA. You will partner with MSO and SMT to prepare scientific safety analyses and evaluate data for regulatory decisions in both marketed and development-stage products.

The role requires at least six years of experience, a health-related bachelor’s, and excellent communication. You will mentor SASs, lead data reviews, and support audits and health authority