At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Product Safety

Job Sub Function:

Product Safety Risk Management

Job Category:

People Leader

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

About Innovative Medicine:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
 

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
 

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Director, Safety Analysis Scientist Team Lead to be onsite in Titusville, NJ, Raritan, NJ or Horsham, PA.

Purpose:
The Director, Safety Analysis Scientist (SAS) Team Lead will be responsible for oversight of scientific safety analyses and evaluations, which are required for regulatory compliance and to aid in safety-related decisions for marketed products and products in development. The SAS Team Lead will manage a group of scientists who support product Safety Management Teams (SMTs) and work in close collaboration with other safety partners to determine a product’s safety strategy, complete safety analyses and evaluations, proactively review safety data/lead safety data review meetings and interpret safety information to make a recommendation. The SAS Team Lead will partner with the Product Safety Head and/or Therapeutic Area Safety Head (TASH) and other functions within and outside of Global Medical Safety (GMS) to oversee the strategic messaging and safety profile of company products provided in all deliverables. The SAS Team Lead will mentor and train their staff to ensure accurate and timely analyses and well written assessments of safety data for both scheduled aggregate and ad hoc safety reports, as well as contributing to other function’s deliverables as appropriate.
 

You will be responsible for:

• Manage the team’s resource needs and lead (direct, train, motivate, evaluate) the scientific personnel to:
  • Develop strong product knowledge
  • Provide proactive surveillance of assigned product(s)
  • Demonstrate leadership in the SMT
  • Support the Medical Safety Officer (MSO)
  • Set the safety analysis strategy and conduct strong data analysis
  • Write clear and concise safety evaluations
  • Lead ad hoc report and Health Hazard Evaluation (HHE) development
  • Articulate the impact and medical importance of the analysis
  • Lead safety data review meetings
  • Adhere to policies, procedure, and regulations
• Collaborate with other safety leaders to ensure high quality safety reports and to guide decision making. Partner with GMS leadership to enable the scientific analysis and reporting responsibilities of the group to maintain regulatory compliance and produce high quality safety evaluations.
• Oversee the safety data review process to evaluate safety data proactively and form a safety position across GMS which can be leveraged for aggregate safety reports.
• Support Pharmacovigilance (PV) audits and inspections.
  
   

Qualifications / Requirements:

Education:

• Minimum of a Bachelor’s degree is required 
• Advanced degree is preferred

Required:

• Minimum 10 years of experience in Pharmacovigilance, Aggregate Reporting, or comparable regulated environment
• Knowledge of global regulatory framework for aggregate safety reports
• Experience in developing aggregate safety reports [e.g., Periodic Benefit-Risk Evaluation Report (PBRER)]
• 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 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 plan work to meet deadlines and effectively handle multiple priorities
• Proficiency in Microsoft applications (e.g., Word, Excel, and PowerPoint)

Preferred:

• Leadership in a multi-function organization
• Experience leading in a global organization
• People management experience
  
   

The anticipated base pay range for this position in the US is $164,000 to $282,000.

 

The Company maintains highly competitive, performance-based compensation programs.  Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.  The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year.  Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 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

For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on December 10, 2025.  The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
 

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 
 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

 

#LI-Hybrid

Required Skills:

 

 

Preferred Skills:

 

 

The anticipated base pay range for this position is :

$164,000-282,000

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: 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  Additional information can be found through the link below.  https://www.careers.jnj.com/employee-benefits