Associate Director, Safety Analysis Scientist
Johnson & Johnson Innovative Medicine, Raritan, NJ, United States
Johnson & Johnson is seeking an Associate Director, Safety Analysis Scientist (SAS) in Raritan, NJ; Titusville, NJ; or Horsham, PA. This hybrid position requires on‑site presence three days a week.
Job Function Product Safety
Job Sub Function Product Safety Risk Management
Job Category Scientific/Technology
All Job Posting Locations Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America
About the Team Our Oncology team is focused on discovering new pathways and modalities to eliminate cancer. We think deeply about safety and work across the product life cycle to develop treatments, find cures, and pioneer the path from lab to life while championing patients every step of the way.
Purpose The Associate Director Safety Analysis Scientist (AD SAS) provides scientific expertise and leads the safety assessment of assigned products. In partnership with the Medical Safety Officer (MSO), the AD SAS prepares safety analyses and evaluations required for regulatory compliance and for guiding safety-related decisions on marketed products and on‑going development.
You Will Be Responsible For
Lead safety evaluations, including strategy discussions, data retrieval, analysis, report writing and revision.
Ensure high‑quality safety evaluations and reports with minimal comments and revisions from stakeholders.
Provide input and review of key regulatory or clinical documents as appropriate.
Demonstrate leadership in the Safety Management Team (SMT) and support the MSO.
Support SMT activities such as preparing and presenting data, compiling meeting minutes, and updating signal‑tracking information.
Lead proactive safety data reviews and formulate a safety position across Global Medical Safety (GMS) for aggregate safety reports.
Provide support for Health Authority interactions regarding safety and risk management, both written and verbal.
Assume responsibility for novel projects, create value and innovate without defined processes, seeking guidance from Directors (SAS TAL) when necessary.
Lead cross‑functional training of relevant stakeholders.
Act as product or process Subject Matter Expert (SME) for audits/inspections.
Participate in, or lead, departmental and cross‑functional initiatives.
Explore innovative ways of presenting data, preparing reports, and improving efficiencies within assigned programs.
Assist Directors in the creation, review and implementation of controlled documents and related tools.
Manage unscheduled reports within the Aggregate Report Calendar.
Perform management activities within smaller therapeutic areas, as applicable.
Line‑manage contractor positions within the team, as applicable.
Act as backup to the SAS TAL when required.
Oversee deliverables by other team members (e.g., complex reports), as needed.
Education
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).
Experience
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, with proven leadership skills.
Ability to plan work to meet deadlines and handle multiple priorities.
Proficiency in Microsoft applications (Word, Excel, PowerPoint).
Ability to independently influence, negotiate and communicate with internal and external customers.
Preferred Skills
Clinical experience.
Oncology experience.
Compensation The anticipated base pay range for this position in the U.S. is $137,000 to $235,750.
Benefits
Vacation – up to 120 hours per calendar year
Sick time – up to 40 hours per calendar year; up to 56 hours for employees in Washington state
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 visit https://www.careers.jnj.com/employee-benefits
Posting Status This job posting is anticipated to close on March 12th, 2026. The company may extend this period; the posting will remain available at https://www.careers.jnj.com to accept additional applications.
Equal Opportunity Employment 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
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Job Function Product Safety
Job Sub Function Product Safety Risk Management
Job Category Scientific/Technology
All Job Posting Locations Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America
About the Team Our Oncology team is focused on discovering new pathways and modalities to eliminate cancer. We think deeply about safety and work across the product life cycle to develop treatments, find cures, and pioneer the path from lab to life while championing patients every step of the way.
Purpose The Associate Director Safety Analysis Scientist (AD SAS) provides scientific expertise and leads the safety assessment of assigned products. In partnership with the Medical Safety Officer (MSO), the AD SAS prepares safety analyses and evaluations required for regulatory compliance and for guiding safety-related decisions on marketed products and on‑going development.
You Will Be Responsible For
Lead safety evaluations, including strategy discussions, data retrieval, analysis, report writing and revision.
Ensure high‑quality safety evaluations and reports with minimal comments and revisions from stakeholders.
Provide input and review of key regulatory or clinical documents as appropriate.
Demonstrate leadership in the Safety Management Team (SMT) and support the MSO.
Support SMT activities such as preparing and presenting data, compiling meeting minutes, and updating signal‑tracking information.
Lead proactive safety data reviews and formulate a safety position across Global Medical Safety (GMS) for aggregate safety reports.
Provide support for Health Authority interactions regarding safety and risk management, both written and verbal.
Assume responsibility for novel projects, create value and innovate without defined processes, seeking guidance from Directors (SAS TAL) when necessary.
Lead cross‑functional training of relevant stakeholders.
Act as product or process Subject Matter Expert (SME) for audits/inspections.
Participate in, or lead, departmental and cross‑functional initiatives.
Explore innovative ways of presenting data, preparing reports, and improving efficiencies within assigned programs.
Assist Directors in the creation, review and implementation of controlled documents and related tools.
Manage unscheduled reports within the Aggregate Report Calendar.
Perform management activities within smaller therapeutic areas, as applicable.
Line‑manage contractor positions within the team, as applicable.
Act as backup to the SAS TAL when required.
Oversee deliverables by other team members (e.g., complex reports), as needed.
Education
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).
Experience
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, with proven leadership skills.
Ability to plan work to meet deadlines and handle multiple priorities.
Proficiency in Microsoft applications (Word, Excel, PowerPoint).
Ability to independently influence, negotiate and communicate with internal and external customers.
Preferred Skills
Clinical experience.
Oncology experience.
Compensation The anticipated base pay range for this position in the U.S. is $137,000 to $235,750.
Benefits
Vacation – up to 120 hours per calendar year
Sick time – up to 40 hours per calendar year; up to 56 hours for employees in Washington state
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 visit https://www.careers.jnj.com/employee-benefits
Posting Status This job posting is anticipated to close on March 12th, 2026. The company may extend this period; the posting will remain available at https://www.careers.jnj.com to accept additional applications.
Equal Opportunity Employment 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
#J-18808-Ljbffr