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Senior Director, Product Safety – Cellular Therapy, Hematology
Johnson & JohnsonProduct Safety Head overseeing safety strategy for cellular therapy products at Johnson & Johnson. Leading a team and ensuring compliance while managing safety assessments and risk management.
ATS Keywords
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Hard Skills
clinical medicinepharmacovigilancecellular therapy product developmentsafety data assessmentprocess improvementSOP developmentregulatory inspection readiness
Soft Skills
leadershipmanagementinfluencenegotiationcommunicationproblem-solvingmultitasking
Certifications & Qualifications
Medical Degree
Industry Keywords
Pharmaceutical Industrycellular therapysafety strategyrisk managementmedical safety processessafety representativePV guidelines
About the role
Key responsibilities & impact- Shape the safety strategy and risk management for multiple cellular therapy products
- Partner closely with various leadership roles for proactive assessments of safety data
- Provide oversight and leadership to Medical Safety Officers
- Ensure consistency of medical safety-related processes and implement needed process improvements
- Serve as Safety Representative on relevant committees
- Support regulatory inspection readiness and develop or revise SOPs
- Create a diverse workforce by promoting inclusion
Requirements
What you’ll need- Medical Degree or equivalent
- 8 or more years of substantial Pharmaceutical Industry experience
- Management experience in supervising a group of employees
- Significant skills in clinical medicine and pharmacovigilance
- Knowledge of cellular therapy products and the associated PV guidelines
- Demonstrated in-depth knowledge of principles of cellular therapy product development
- Proven track record in dealing with difficult safety issues
- Ability to successfully manage multiple critical issues simultaneously
- Ability to influence, negotiate and communicate effectively
- Excellent verbal and written communication skills
Benefits
Comp & perks- Health insurance
- 401(k) matching
- Flexible working hours
- Paid time off
- Professional development opportunities