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Associate Director – Safety Analysis Scientist
Johnson & Johnson. Lead safety evaluations, including strategy discussions, data retrieval, data analysis, report writing, and report revision .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in safety evaluations, medical writing, and pharmacovigilance, with a strong ability to analyze complex medical data and effectively communicate findings. Proven leadership in cross-functional teams and stakeholder interactions, ensuring high-quality safety reports and compliance with regulatory requirements.
Highest-signal resume keywords
Medical Writing ExperiencePharmacovigilance ExpertiseData Analysis SkillsLeadership in Safety ManagementRegulatory Document Review
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 RetrievalData AnalysisReport WritingSignal TrackingComplex Data InterpretationProject ManagementTraining DevelopmentAudit PreparationTherapeutic Area Management
Soft Skills
Excellent Communication SkillsStakeholder InteractionMatrix Environment CollaborationInfluencing and NegotiationDeadline Management
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPoint
Industry Keywords
HealthcareBiomedical ScienceDrug DevelopmentPost Marketing SafetyGlobal Safety Requirements
About the role
Key responsibilities & impact- Lead safety evaluations, including strategy discussions, data retrieval, data analysis, report writing, and report revision
- Ensure high-quality safety evaluations and reports
- Provide input and review of 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
- Support Health Authority interactions regarding safety and risk management
- Assume responsibility for novel projects and innovate without defined processes
- Lead cross-functional training of relevant stakeholders
- Act as product or process Subject Matter Expert for audits and inspections
- Participate in or lead department and cross-functional initiatives
- Explore innovative ways to present data, prepare reports, and improve program efficiencies
- Assist Directors with controlled documents and related tools
- Manage unscheduled reports within the Aggregate Report Calendar
- Manage activities within smaller Therapeutic Areas, as applicable
- Line-manage contractor positions within the team, as applicable
- Act as backup to the Therapeutic Area Lead as needed
- Oversee deliverables prepared by other team members
Requirements
What you’ll need- Bachelor’s Degree Required: Healthcare-related or Biomedical Science (11+ years industry experience or equivalent)
- Advanced Degree Preferred: Healthcare-related or Biomedical Science (8+ years industry experience or equivalent)
- Medical writing or Pharmacovigilance (PV) experience required
- Working knowledge of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements
- Ability to understand and analyze complex medical-scientific data from a broad range of disciplines
- Ability to interpret and present complex data to determine benefit-risk impact
- Excellent English 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 independently influence, negotiate, and communicate with internal and external customers
Benefits
Comp & perks- Annual performance bonus
- Medical, dental, and vision insurance
- Life insurance
- Short- and long-term disability insurance
- Business accident insurance
- Group legal insurance
- Pension plan
- 401(k) savings plan
- Vacation – up to 120 hours per calendar year
- Sick time – up to 40 hours per calendar year
- Holiday pay, including Floating Holidays – up to 13 days per calendar year
- Work, Personal and Family Time – up to 40 hours per calendar year
- Long-term incentive program
- 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