Manager, Safety Analysis Scientist - Cell Therapy

Johnson & Johnson Co.; Raritan (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Johnson & Johnson is seeking a Manager, Safety Analysis Scientist - Cell Therapy based in the United States, with responsibility for scientific safety analyses and regulatory-compliant evaluations for marketed and development-stage products.

You will lead safety evaluations, collaborate with MSO and SMT, review data, and drive proactive safety data reviews to support health authority interactions and cross-functional safety decisions.

Qualifications

• Minimum 6 years of clinical and/or industry experience.
• Familiarity with safety activities in drug development and regulatory requirements.
• Ability to analyze complex medical data from diverse sources.
• Ability to present data to determine benefit-risk impact.

Responsibilities

• Lead safety evaluations and strategies in collaboration with MSO and SMT.
• Ensure high-quality safety reports with minimal revisions.
• Support novel projects and provide input on regulatory/clinical documents.
• Lead proactive safety data review meetings and safety position development.

Skills

Leadership

Safety analysis

Data analysis

Regulatory knowledge

Communication

Cross-functional collaboration

Education

Bachelor's degree in healthcare/biomedical

Advanced degree preferred

Tools

SAS

Excel

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.

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 a Manager, Safety Analysis Scientist - Cell Therapy based in Raritan, NJ, Titusville, NJ, or Horsham, PA.

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.

Purpose:

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.

Your will be responsible for:

• 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.

Qualifications / Requirements:

Education:

• Minimum of a Bachelor's degree in a healthcare-related field or biomedical science is required
• Advanced degree is preferred

Required:

• 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.