Manager, Safety Analysis Scientist

6084-Janssen Research & Development, LLC Legal Entity; Horsham (PA); On-site; USD 117,000 - 201,000; Full time

Job summary

Johnson & Johnson is seeking a Manager, Safety Analysis Scientist to be based in Horsham, PA; Titusville, NJ; or Raritan, NJ. The role provides scientific leadership for safety assessments of assigned products, partnering with the MSO to support compliance and safety decisions.

You will mentor teammates, lead safety evaluations, and contribute to regulatory documents while coordinating with cross-functional teams to ensure rigorous safety analyses.

Qualifications

• Experience in medical writing or PV required.
• Clinical experience preferred.
• Strong ability to analyze complex medical data and present it clearly.

Responsibilities

• Lead safety evaluations, including strategy discussions and data analysis.
• Ensure high quality safety evaluations with minimal revisions.
• Support AD SASs on novel projects.
• Provide input to regulatory and clinical documents.
• Demonstrate leadership in SMT and support the MSO.
• Support SMT activities and data presentations.
• Lead proactive safety data reviews.

Skills

Business Alignment

Clinical Operations

Coaching

Compliance Management

Compliance Risk

Critical Thinking

Data Reporting

Medicines Development

Regulation

Organizing

Quality Control

Research Ethics

Risk Management

Safety Investigations

SOP

Technical Writing

Serious Adverse Events

Education

Bachelor's in Healthcare/ Biomedical Science

Advanced Degree in Healthcare/ Biomedical Science

Tools

Microsoft Office

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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: We are searching for the best talent for our Manager, Safety Analysis Scientist to be located in Horsham, PA; Titusville, NJ; or Raritan, NJ.

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

Purpose:

The Manager, Safety Analysis Scientist (SAS) provides scientific expertise for the safety assessment of assigned products, partnering with the Medical Safety Officer (MSO) to support regulatory compliance and safety-related decision-making for marketed and in-development products. With in-depth product knowledge, the Manager SAS serves as the product point of contact and mentors team members on complex reports. The role operates independently or with moderate guidance from the Director, SAS Therapeutic Area Lead (TAL), building the cross-functional alliances needed to shape safety-related decisions and outcomes. You will be responsible for:

• Leading safety evaluations, including strategy discussions, collaborating with Therapeutic Area Safety Head (TASH)/MSO and other team members as necessary, data retrieval, data analysis, report writing, and report revision.
• Ensuring high quality safety evaluations and reports with minimal-to-moderate comments from team members and minimal-to-moderate revisions required.
• Providing support to AD SASs for novel projects without defined processes.
• Providing input and review to 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.

Qualifications/Requirements

• 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).
• Medical writing or PV experience required.
• Clinical experience preferred.
• 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 sources 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 effectively interact with team members, including business partners is required.
• Ability to work in a cross-functional team environment, proven leadership skills is required.
• Ability to plan work to meet timelines and effectively balance multiple priorities is required.
• Proficiency in Microsoft applications (e.g. Word, Excel, and PowerPoint) is required.
• Ability to influence, negotiate and connect with both internal and external customers is required.

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.

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check #LI-Hybrid

Required Skills: Business Alignment, Clinical Operations, Coaching, Compliance Management, Compliance Risk, Critical Thinking, Data Reporting, Medicines and Device Development and Regulation, Organizing, Quality Control (QC), Research Ethics, Researching, Risk Management, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Technical Writing

Preferred Skills: Business Alignment, Clinical Operations, Coaching, Compliance Management, Compliance Risk, Critical Thinking, Data Reporting, Medicines and Device Development and Regulation, Organizing, Quality Control (QC), Research Ethics, Researching, Risk Management, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Technical Writing

The anticipated base pay range for this position is : $117,000.00 - $201,250.00

Additional Description for Pay Transparency:

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)).

• 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 period
• 10 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

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.

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