Johnson & Johnson

Associate Director, Safety Analysis Scientist

Johnson & Johnson

full-time

Posted on:

Location Type: Hybrid

Location: Horsham • New Jersey • Pennsylvania • United States

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Salary

💰 $137,000 - $235,750 per year

Job Level

Senior

About the role

  • Leading safety evaluations including strategy discussions, collaborating with Therapeutic Area Safety Head (TASH)/MSO and other partners as necessary, data retrieval, data analysis, report writing, and report revision.
  • Ensuring high quality safety evaluations and reports with minimal comments from partners and minimal revisions required.
  • Providing input and review of key regulatory or clinical documents as appropriate.
  • Demonstrating leadership in the SMT and support the MSO.
  • Supporting SMT activities (e.g., preparing and presenting data, compiling meeting minutes, updating signal tracking information).
  • Leading proactive safety data reviews, if applicable and form a safety position across Global Medical Safety (GMS) which can be used for aggregate safety reports.
  • Providing support for Health Authority interactions regarding safety and risk management, both written and verbal.
  • Assuming responsibility for novel projects, bringing value and innovation without defined processes.
  • May seek guidance from Directors (i.e., SAS TAL) for complex projects.
  • Leading cross-functional training of relevant partners.
  • Acting as product or process Subject Matter Expert (SME) for audits/inspections.
  • Participating in, or leading, department and/or cross-functional initiatives.
  • Exploring innovative ways of presenting data, preparing reports, and improving efficiencies within the programs they own.
  • Assisting Directors in the creation, review and implementation of controlled documents and other related tools.
  • Managing unscheduled reports within the Aggregate Report Calendar.
  • Managing activities within smaller Therapeutic Areas, as applicable.
  • Line-management of contractor positions within the team, as applicable.
  • Acting as backup to TAL as needed (e.g., Director SAS TAL is unavailable).

Requirements

  • A minimum of a Bachelor’s degree in Biomedical Science or a Healthcare related field is required
  • 8+ years of relevant experience is required
  • Medical writing or Pharmacovigilance (PV) experience is required
  • Working knowledge of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements is required
  • Ability to understand and analyze complex medical-scientific data from a broad range of fields is required
  • Ability to interpret and present complex data to determine benefit-risk impact is required
  • Excellent English verbal and written communication skills is required
  • Ability to plan work to meet deadlines and effectively balance multiple priorities is required
  • Ability to effectively interact with team members, including business partners is preferred
  • Ability to work in a matrix environment, proven leadership skills is preferred
  • Proficiency in Microsoft applications (e.g., Word, Excel, and PowerPoint) is preferred
  • Ability to independently influence, negotiate and communicate with both internal and external customers is preferred
  • Clinical experience is preferred.
Benefits
  • medical, dental, vision, life insurance
  • short- and long-term disability
  • business accident insurance
  • group legal insurance
  • retirement plan (pension)
  • savings plan (401(k))
  • Vacation –120 hours per calendar year
  • Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 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
  • Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
  • Caregiver Leave – 10 days
  • Volunteer Leave – 4 days
  • Military Spouse Time-Off – 80 hours
Applicant Tracking System Keywords

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

Hard Skills & Tools
medical writingpharmacovigilancedata analysissafety evaluationsreport writingdata retrievalcomplex medical-scientific data analysisbenefit-risk impact assessmentsafety data reviewscontrolled document implementation
Soft Skills
leadershipcommunicationplanningprioritizationteam interactioninfluencenegotiationpresentationcollaborationinnovation