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Manager, Safety Analysis Scientist – Cell Therapy
Johnson & Johnson. Prepare scientific safety analyses and evaluations for regulatory compliance and safety-related decisions .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in safety analysis and regulatory compliance, with a strong ability to interpret complex medical data and lead cross-functional safety initiatives. Proven leadership in safety management and effective communication with stakeholders is essential.
Highest-signal resume keywords
Safety AnalysisRegulatory ComplianceData InterpretationLeadership SkillsMedical Concepts
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Safety EvaluationsData AnalysisReport WritingClinical Document ReviewSafety Data ReviewBenefit-Risk AssessmentCross-Functional CollaborationMatrix Environment WorkControlled Document ImplementationHealth Authority Interaction
Soft Skills
Excellent Communication SkillsStakeholder InteractionMentoringNegotiation SkillsPlanning and Prioritization
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPoint
Industry Keywords
HealthcareBiomedical ScienceDrug DevelopmentPost Marketing SafetyGlobal Safety Requirements
About the role
Key responsibilities & impact- Prepare scientific safety analyses and evaluations for regulatory compliance and safety-related decisions
- Support Product Safety Management Teams and collaborate with cross-functional safety partners
- Determine product safety strategy
- Complete safety analyses and evaluations for ad hoc and scheduled reports
- Proactively review safety data
- Lead safety data review meetings and support Safety Management Team deliverables
- Lead safety evaluations, including strategy discussions, data retrieval, data analysis, report writing, and report revision
- Support Associate Director Safety Analysis Scientists on novel projects without defined processes
- Provide input to and review key regulatory or clinical documents
- Demonstrate leadership in the Safety Management Team and support the Medical Safety Officer
- Prepare and present data, compile meeting minutes, and update signal tracking information
- Lead proactive safety data reviews and form safety positions across Global Medical Safety for aggregate safety reports
- Support written and verbal Health Authority interactions regarding safety and risk management
- Contribute to cross-functional training
- Mentor other Safety Analysis Scientists
- Participate in departmental and cross-functional initiatives
- Explore innovative ways to present data, prepare reports, and improve efficiencies
- Assist in creating, reviewing, and implementing controlled documents and related tools
- Support audits and inspections
Requirements
What you’ll need- Minimum of a Bachelor’s degree in a healthcare-related field or biomedical science is required
- Minimum of 6 years of relevant clinical and/or industry experience
- Working knowledge of medical concepts
- Familiarity with safety activities in drug development and post marketing
- Familiarity with 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 Word, Excel, and PowerPoint
- Ability to influence, negotiate and communicate with internal and external customers
- Candidates must already have authorization to work in the country of employment
- Immigration sponsorship and relocation support are not available
- Candidates requiring future immigration sponsorship are not eligible
Benefits
Comp & perks- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
- Vacation – 120 hours per calendar year
- Sick time – 40 hours per calendar year
- Holiday pay, including Floating Holidays – 13 days per calendar year
- Work, Personal and Family Time – up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
- Inclusive interview process and disability accommodations