Manager, Safety Analysis Scientist – Cell Therapy
Johnson & Johnson Innovative Medicine
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Job summary
Johnson & Johnson is seeking a Manager, Safety Analytics Scientist – Cell Therapy, to lead scientific safety analyses for products in development or on the market. The role supports SMTs and collaborates with global safety partners to shape safety strategy and data-driven decisions.
Based in Raritan, NJ, Titusville, NJ, or Horsham, PA, the candidate will review safety data, prepare reports, and mentor other SASs while engaging with Health Authorities when needed.
Qualifications
- Minimum of 6 years of relevant clinical and/or industry experience.
- Working knowledge of medical concepts and familiarity with safety activities in drug development 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 work in a matrix environment, proven leadership skills.
- Ability to plan work to meet deadlines and effectively handle multiple priorities.
- Proficiency in Microsoft applications (Word, Excel, PowerPoint).
- Ability to influence, negotiate and communicate with both internal and external customers.
Responsibilities
- Lead safety evaluations, including strategy discussions, collaborating with TASH/MSO and other stakeholders as necessary, data retrieval, analysis, reporting, and revisions.
- Ensure high-quality safety evaluations and reports with minimal-to-moderate comments and revisions.
- Provide support to Associate Directors for novel projects without defined processes.
- Input and review of key regulatory or clinical documents as appropriate.
- Demonstrate leadership in the SMT and support the MSO.
- Support SMT activities (data preparation, meeting minutes, signal tracking).
- Lead proactive safety data reviews and contribute to aggregate safety reports.
- Support health authority interactions regarding safety and risk management.
Skills
Education
Tools
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 jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Product Safety
Product Safety Risk Management
Scientific/Technology
Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America
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
Candidates must already have authorization to work in the country of employment. Immigration sponsorship and relocation support are not available for this position. Candidates authorized to work pursuant to a short-term status (e.g., F-1) who require future immigration sponsorship are not eligible.
The Manager SAS, 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 Manager 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 for ad hoc and scheduled reports, proactively review safety data, and lead safety data review meetings, supporting SMT deliverables.
- Lead safety evaluations, including strategy discussions, collaborating with Therapeutic Area Safety Head (TASH)/MSO and other stakeholders as necessary, data retrieval, data analysis, report writing, and report revision.
- Ensure high-quality safety evaluations and reports with minimal-to-moderate comments from stakeholders and minimal-to-moderate revisions required.
- Provide support to Associate Director (AD) SASs for novel projects without defined processes.
- Provide input and review of key regulatory or clinical documents as appropriate.
- Demonstrate leadership in the SMT and support the MSO.
- Support SMT activities (e.g., preparing and presenting data, compiling meeting minutes, updating signal tracking information).
- Lead proactive safety data reviews, if applicable and form a safety position across Global Medical Safety (GMS) which can be leveraged for aggregate safety reports.
- Provide support for Health Authority interactions regarding safety and risk management, both written and verbal.
- Contribute to cross-functional training of relevant stakeholders.
- Mentor other SASs on activities within the role.
- Participate in department and/or cross-functional initiatives and explore innovative ways of presenting data, preparing reports, and improving efficiencies.
- Assist in the creation, review and implementation of controlled documents and other related tools.
- Support audits/inspections.
- Minimum of a Bachelor’s degree in a healthcare-related field or biomedical science is required
- Advanced degree is preferred
- Minimum of 6 years of relevant clinical and/or industry experience.
- 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 work in a matrix environment, proven leadership skills.
- Ability to plan work to meet deadlines and effectively handle multiple priorities.
- Proficiency in Microsoft applications (e.g., Word, Excel, and PowerPoint).
- Ability to influence, negotiate and communicate with both internal and external customers.
- Clinical experience
- Medical writing or Pharmacovigilance (PV) experience
- Experience in cell therapy and/or oncology
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.
$120,000.00 - $207,000.00
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 Colorado –48 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
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
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