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:

US063 NJ Raritan - 920 US Hwy 202, US159 NJ Titusville - 1125 Trenton-Harbourton Rd, US176 PA Horsham - 850 Ridgeview Dr

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

About Oncology

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.

Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results.

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

This is a hybrid role available in multiple states and cities within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from various locations to apply and encourage you to review the following states and cities where this opportunity is available:

Raritan, NJ

Titusville, NJ

Horsham, PA

We are searching for the best talent for Manager, Safety Analysis Scientist, located in Raritan, NJ; Titusville, NJ; or Horsham, PA.

Purpose:

The Manager Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products. 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 settle 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 Manager SAS will assist the MSO with activities related to the SMT and with contributions to key safety and clinical documents.

The Manager SAS will have in-depth product knowledge, will serve as product point of contact, and will provide mentoring to, and oversight of deliverables prepared by, other team members as needed (for complex reports).

The Manager SAS will function independently, or with moderate guidance from the Director, SAS Therapeutic Area Lead (TAL), be able to link discussions to content, and deliver quality results with minimal guidance. The Manager SAS will build alliances and be able to influence other safety partners to shape decisions/outcomes.

You 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 AD SASs for novel projects without defined processes.

Provide input and review to 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 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:

Bachelor’s Degree Required: Healthcare-related or Biomedical Science (9+ years industry experience or equivalent).

Advanced Degree Preferred: Healthcare-related or Biomedical Science (6+ years industry experience or equivalent).

Experience

Required:

Working knowledge of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements.

Medical writing or PV experience.

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 English 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.

Preferred:

Clinical experience.

The anticipated base pay range for this position in all other U.S. locations is $115,000 to $197,800.

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

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

This job posting is anticipated to close on March 17th, 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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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