Johnson & Johnson

Associate Director – Safety Analysis Scientist

Johnson & Johnson

full-time

Posted on:

Location Type: Hybrid

Location: Spring House • California • Florida • United States

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Salary

💰 $137,000 - $235,750 per year

Job Level

Senior

About the role

  • Lead proactive safety data reviews and form a safety position across JJEI which can be leveraged for aggregate safety reports
  • Support SMT activities (e.g. preparing and presenting data, compiling meeting minutes, updating signal tracking information)
  • Demonstrate leadership in the SMT and support the SSO
  • Drive safety evaluations including risk-benefit discussions, collaborating with SSO and other stakeholders as necessary, data retrieval, data analysis, report writing, and report revision
  • Provide input and review to key regulatory or clinical documents as appropriate
  • Assume responsibility for novel projects, create value and innovate without defined processes
  • May seek guidance from senior leadership for complex projects
  • Lead cross-functional training of relevant stakeholders
  • Act as safety database querying Subject Matter Expert (SME) for audits/inspections
  • Participate in or lead department and/or cross-functional initiatives
  • Explore innovative ways of presenting data, preparing reports, and improving efficiencies within the programs they own
  • Assist SSO and operational leads in the creation, review and implementation of controlled documents and other related tools
  • Management of unscheduled reports within the Aggregate Report Calendar
  • Liaison activities within pharmaceutical and medical technology sectors, as applicable
  • Line-management of contractor positions within the team, as applicable
  • Oversight of deliverables by other team members (e.g. complex reports), as needed

Requirements

  • Bachelor's degree in a healthcare or biomedical science discipline and 11+ years of industry experience required
  • Master's degree in a healthcare or biomedical science discipline and 8+ years of experience or a PharmD/PhD in a healthcare or biomedical science discipline and 5+ years of experience preferred
  • Medical writing or PV experience required
  • Clinical experience preferred
  • Working knowledge of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements required
  • Ability to understand and analyze complex medical-scientific data from a broad range of disciplines required
  • Ability to interpret and present complex data to determine benefit-risk impact required
  • Excellent English verbal and written communication skills required
  • Ability to effectively interact with stakeholders, including business partners required
  • Ability to work in a matrix environment, proven leadership skills required
  • Ability to plan work to meet deadlines and effectively handle multiple priorities required
  • Proficiency in Microsoft applications (e.g. Word, Excel, and PowerPoint) required
  • Ability to independently influence, negotiate and communicate with both internal and external customers required
Benefits
  • Retirement plan (pension) and savings plan (401(k))
  • Vacation – 120 hours per calendar year
  • Sick time – 40 hours per calendar year; 48 hours for Colorado residents; 56 hours for Washington residents
  • 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 immediate family; 40 hours for extended family 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
medical writingpharmacovigilancedata analysisreport writingrisk-benefit analysissafety evaluationsdata retrievalcomplex data interpretationclinical experiencesafety database querying
Soft Skills
leadershipcommunicationstakeholder interactionmatrix environment collaborationplanning and organizationnegotiationinfluencemulti-priority managementtraininginnovation