Associate Director, Safety Analysis Scientist

Johnson & Johnson

. Provide scientific expertise and lead safety assessments for assigned products .

Posted 10/5/2026full-timeUnited StatesSenior💰 $137,000 - $235,750 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in safety assessments and regulatory compliance, with a strong background in Medical Writing and Pharmacovigilance. Capable of leading cross-functional teams and effectively communicating complex medical data to stakeholders.

Highest-signal resume keywords

Medical Writing ExperiencePharmacovigilance ExpertiseRegulatory Compliance KnowledgeData Analysis SkillsLeadership in Cross-Functional Teams

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Safety AssessmentsData InterpretationReport WritingSafety Data ReviewClinical ExperienceMedical Concepts KnowledgeBenefit-Risk AnalysisSignal Tracking

Soft Skills

Excellent Communication SkillsStakeholder InteractionMatrix Environment CollaborationLeadership SkillsNegotiation Skills

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPoint

Industry Keywords

HealthcareBiomedical ScienceDrug DevelopmentPost-Marketing SafetyGlobal Safety Health Authority Requirements

About the role

Key responsibilities & impact

Provide scientific expertise and lead safety assessments for assigned products
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 on product safety strategy
Complete safety analyses and evaluations, proactively review safety data, lead safety data review meetings, and interpret safety information
Assist the Medical Safety Officer with Safety Management Team activities and key safety and clinical documents
Serve as product point of contact and provide product knowledge, training, and oversight of team deliverables
Lead safety evaluations, including strategy discussions, data retrieval, data analysis, report writing, and report revision
Provide input on and review key regulatory and clinical documents
Prepare and present data, compile meeting minutes, and update signal-tracking information
Lead proactive safety data reviews and form safety positions for aggregate safety reports
Support written and verbal Health Authority interactions regarding safety and risk management
Lead cross-functional training and act as a Subject Matter Expert for audits and inspections
Participate in or lead department and cross-functional initiatives
Improve data presentation, report preparation, and program efficiencies
Assist 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, 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 in Healthcare-related or Biomedical Science
11+ years industry experience or equivalent with a bachelor’s degree
Advanced degree in Healthcare-related or Biomedical Science preferred
8+ years industry experience or equivalent with an advanced degree
Medical writing or Pharmacovigilance (PV) experience required
Clinical experience preferred
Working knowledge of medical concepts and 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 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 and business partners
Ability to work in a matrix environment and demonstrate leadership skills
Ability to plan work, meet deadlines, and 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

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; 48 hours for employees residing in Colorado; 56 hours for employees residing in Washington
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