Manager, Safety Analysis Scientist

About the role

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.

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.

This position may be based in Horsham, PA; Titusville, NJ; or Raritan, NJ.

Responsibilities

• 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.

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.

Skills

• Business Alignment
• Clinical Operations
• Coaching
• Compliance Management