Manager, Safety Analysis Scientist

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

Johnson & Johnson is seeking a Manager, Safety Analysis Scientist to provide scientific expertise and lead the safety assessment of assigned products. This role involves preparing scientific safety analysis and evaluations for regulatory compliance and decision-making, collaborating with cross-functional teams, and mentoring other scientists. The position requires a strong understanding of product safety, data analysis, and regulatory interactions within the healthcare industry.

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-to-moderate comments from stakeholders and minimal-to-moderate revisions required.
  3. Provide support to AD SASs for novel projects without defined processes.
  4. Provide input and review to key regulatory or clinical documents as appropriate.
  5. Demonstrate leadership in the SMT and support the MSO.

Skills

Required

  • scientific expertise
  • safety assessment
  • data analysis
  • report writing
  • regulatory compliance
  • collaboration
  • mentoring

Nice to have

  • product knowledge
  • cross-functional training
  • Health Authority interactions