Safety Analysis Manager – Drug Safety Leadership

6084-Janssen Research & Development, LLC Legal Entity

Horsham (PA)

On-site

USD 117,000 - 201,000

Full time

7 days ago

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Job summary

Johnson & Johnson is seeking a Manager, Safety Analysis Scientist to be based in Horsham, PA; Titusville, NJ; or Raritan, NJ. The role provides scientific leadership for safety assessments of assigned products, partnering with the MSO to support compliance and safety decisions.

You will mentor teammates, lead safety evaluations, and contribute to regulatory documents while coordinating with cross-functional teams to ensure rigorous safety analyses.

Qualifications

Experience in medical writing or PV required.
Clinical experience preferred.
Strong ability to analyze complex medical data and present it clearly.

Responsibilities

Lead safety evaluations, including strategy discussions and data analysis.
Ensure high quality safety evaluations with minimal revisions.
Support AD SASs on novel projects.
Provide input to regulatory and clinical documents.
Demonstrate leadership in SMT and support the MSO.
Support SMT activities and data presentations.
Lead proactive safety data reviews.

Skills

Business Alignment

Clinical Operations

Coaching

Compliance Management

Compliance Risk

Critical Thinking

Data Reporting

Medicines Development

Regulation

Organizing

Quality Control

Research Ethics

Risk Management

Safety Investigations

SOP

Technical Writing

Serious Adverse Events

Education

Bachelor's in Healthcare/ Biomedical Science

Advanced Degree in Healthcare/ Biomedical Science

Tools

Microsoft Office

Job description

You will mentor teammates, lead safety evaluations, and contribute to regulatory documents while coordinating with cross-functional teams to ensure rigorous safety analyses.

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