Safety Analysis Manager, Cell Therapy

Johnson & Johnson Co.; Horsham (PA); Presencial; USD 120.000 - 207.000; Tempo integral

Benefícios oferecidos por esta vaga

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year

Holiday pay, 13 days per calendar year

Work, Personal and Family Time - up to

Parental Leave – 480 hours within one

Bereavement Leave – 240 hours for an

Caregiver Leave – 80 hours in a 52‑wk

Volunteer Leave – 32 hours per year

Military Spouse Time-Off – 80 hours

Resumo da vaga

Johnson & Johnson is seeking a Manager, Safety Analytics Scientist – Cell Therapy, to lead scientific safety analyses for products in development or on the market. The role supports SMTs and collaborates with global safety partners to shape safety strategy and data-driven decisions.

Based in Raritan, NJ, Titusville, NJ, or Horsham, PA, the candidate will review safety data, prepare reports, and mentor other SASs while engaging with Health Authorities when needed.

Qualificações

• Minimum of 6 years of relevant clinical and/or industry experience.
• Working knowledge of medical concepts and familiarity with safety activities in drug development and global safety health authority requirements.
• Ability to understand and analyze complex medical-scientific data from a broad range of sources.
• Ability to interpret and present complex data to determine benefit-risk impact.
• Excellent verbal and written communication skills.
• Ability to effectively interact with stakeholders, including business partners.
• Ability to work in a matrix environment, proven leadership skills.
• Ability to plan work to meet deadlines and effectively handle multiple priorities.
• Proficiency in Microsoft applications (Word, Excel, PowerPoint).
• Ability to influence, negotiate and communicate with both internal and external customers.

Responsabilidades

• Lead safety evaluations, including strategy discussions, collaborating with TASH/MSO and other stakeholders as necessary, data retrieval, analysis, reporting, and revisions.
• Ensure high-quality safety evaluations and reports with minimal-to-moderate comments and revisions.
• Provide support to Associate Directors for novel projects without defined processes.
• Input and review of key regulatory or clinical documents as appropriate.
• Demonstrate leadership in the SMT and support the MSO.
• Support SMT activities (data preparation, meeting minutes, signal tracking).
• Lead proactive safety data reviews and contribute to aggregate safety reports.
• Support health authority interactions regarding safety and risk management.

Conhecimentos

Clinical/industry experience

Safety analytics

Data interpretation

Stakeholder communication

Leadership in matrix environment

Project planning

Microsoft Office

Formação

Bachelor’s degree in healthcare/biomedical science

Advanced degree preferred

Ferramentas

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Descrição da vaga

Johnson & Johnson is seeking a Manager, Safety Analytics Scientist – Cell Therapy, to lead scientific safety analyses for products in development or on the market. The role supports SMTs and collaborates with global safety partners to shape safety strategy and data-driven decisions.

Based in Raritan, NJ, Titusville, NJ, or Horsham, PA, the candidate will review safety data, prepare reports, and mentor other SASs while engaging with Health Authorities when needed.