Manager, Safety Analysis Scientist

Johnson & Johnson•Titusville, NJ

1d•$117,000 - $201,250•Hybrid

About The Position

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, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America 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 Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United Kingdom- Requisition Number : R-081594 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. We are searching for the best talent for a Manager, Safety Analysis Scientist, located in Raritan, NJ; Titusville, NJ; Spring House, PA; or Horsham, PA. This is a hybrid position that requires you to be on site three days a week. 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 determine 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.

Requirements

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

Nice To Haves

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

Responsibilities

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.

Benefits

medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
consolidated retirement plan (pension) and savings plan (401(k)).
long-term incentive program.
Vacation - 120 hours per calendar year
Sick time - 40 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
Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave - 10 days
Volunteer Leave - 4 days
Military Spouse Time-Off - 80 hours