Associate Director, Safety Analysis Scientist

Johnson & Johnson Johnson & Johnson · Pharma · Raritan, NJ +4

This role provides scientific expertise and leads the safety assessment of assigned products, preparing scientific safety analysis and evaluations for regulatory compliance and safety-related decisions. It involves supporting Safety Management Teams, collaborating with cross-functional partners, reviewing safety data, and providing input on key safety and clinical documents. The role requires in-depth product knowledge, leadership in SMTs, and support for Health Authority interactions.

What you'd actually do

  1. Lead safety evaluations including strategy discussions, collaborating with Therapeutic Area Safety Head (TASH)/MSO and other stakeholders as necessary, data retrieval, data analysis, report writing, and report revision.
  2. Ensure high quality safety evaluations and reports with minimal comments from stakeholders and minimal revisions required.
  3. Provide input and review of key regulatory or clinical documents as appropriate.
  4. Demonstrate leadership in the SMT and support the MSO.
  5. Support SMT activities (e.g., preparing and presenting data, compiling meeting minutes, updating signal tracking information).

Skills

Required

  • Scientific expertise in safety analysis
  • Experience with regulatory compliance
  • Data analysis and interpretation
  • Report writing
  • Collaboration with cross-functional teams
  • Leadership skills
  • Product knowledge
  • Subject Matter Expertise (SME)

Nice to have

  • Experience in Oncology
  • Experience with Health Authority interactions

What the JD emphasized

  • scientific expertise
  • safety assessment
  • regulatory compliance
  • safety-related decisions
  • product safety strategy
  • safety data review
  • interpret safety information
  • Health Authority interactions
  • high quality safety evaluations
  • minimal comments
  • minimal revisions
  • novel projects
  • innovate without defined processes