Associate Director, Safety Analysis Scientist

Johnson & Johnson; Horsham; Hybrid; USD 137,000 - 236,000; Full time

Job summary

Join a leading healthcare company as an Associate Director, Safety Analysis Scientist, where you will lead safety evaluations and provide expertise essential for regulatory compliance. This role involves partnership with medical safety officers, teamwork across disciplines, and significant responsibilities in managing safety data and reports. Ideal candidates will have a strong background in Biomedical Science and extensive experience in pharmacovigilance.

Benefits

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Vacation time

Sick time

Holiday pay

Qualifications

• 8+ years of relevant experience in medical safety or pharmacovigilance.
• Ability to analyze complex medical data and interpret safety information.
• Excellent verbal and written English communication skills.

Responsibilities

• Lead safety evaluations and collaborate with cross-functional teams.
• Prepare regulatory and clinical documents and ensure safety compliance.
• Participate in department initiatives and act as subject matter expert.

Skills

Medical writing

Pharmacovigilance

Data analysis

Leadership

Communication

Education

Bachelor’s degree in Biomedical Science

Advanced degree (preferred)

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

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:

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

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 an Associate Director, Safety Analysis Scientist to be located in Horsham, PA; Raritan, NJ; or Titusville, NJ.

Purpose: The Associate Director (AD), Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products. In partnership with the Medical Safety Officer (MSO), is responsible for the preparation of scientific safety analysis and evaluations, which are required for regulatory compliance and to aid in safety-related decisions for marketed products and products in development.

The AD, SAS will support product Safety Management Teams (SMTs) and work in close collaboration with other cross-functional 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, supporting SMT deliverables as required.

The AD, SAS will assist the Medical Safety Officer (MSO) with activities related to the SMT and with contributions to key safety and clinical documents. They will have in-depth product knowledge, will serve as product point of contact, and will provide training to, and oversight of deliverables prepared by, other team members as needed (for complex reports).

The AD, SAS will function with a high level of independence, with minimal guidance from the Director, Safety Analysis Scientist (SAS) Therapeutic Area Lead (TAL), be able to link discussions to content, and consistently deliver high quality results with minimal guidance. The AD will quickly build alliances and be able to independently influence other safety partners to shape strong decisions/outcomes.

You will be responsible for:

• 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).

Qualifications / Requirements:

Education:

• A minimum of a Bachelor’s degree in Biomedical Science or a Healthcare related field is required. An advanced degree is preferred.

Experience and Skills:

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.

Preferred:

• 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.

The anticipated base pay range for this position is $137,000 to $235,750.

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 of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
  

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

This job posting is anticipated to close on 07/07/2025. 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 and 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 ([e-mail]) or contact AskGS to be directed to your accommodation resource.

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The anticipated base pay range for this position is :

The anticipated base pay range for this position is $137,000 to $235,750.

Additional Description for Pay Transparency: