This job posting is anticipated to close on Mar 17 2025. We may however extend this time period, in which case the posting will remain available on www.careers.jnj.com to accept additional applications.
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 https://www.jnj.com
Job Function:
Product SafetyJob Sub Function:
Product Safety Risk ManagementJob Category:
Scientific/TechnologyAll Job Posting Locations:
US010 PA Horsham - 800/850 Ridgeview Dr, US063 NJ Raritan - 920 US Hwy 202, US159 NJ Titusville - 1125 Trenton-Harbourton RdJob 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
Remote work options may be considered on a case-by-case basis and if approved by the Company.
We are searching for the best talent for an Associate Director, Safety Analysis Scientist, located in Raritan, NJ; Titusville, NJ; or Horsham, PA.
Purpose:
The Associate Director (AD) Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products. The AD 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 AD 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 AD SAS will assist the Medical Safety Officer (MSO) with activities related to the SMT and with contributions to key safety and clinical documents.
The AD SAS will have in-depth product knowledge, will serve as product point of contact, and will provide training to, and oversight of deliverables prepared by, other team members as needed (for complex reports).
The AD SAS will function with a high level of independence, with minimal guidance from the Director, Safety Analysis Scientist (SAS) Therapeutic Area Lead (TAL), be able to link discussions to content, and consistently deliver high quality results with minimal guidance.
The AD SAS will quickly build alliances and be able to independently influence other safety partners to shape strong 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 comments from stakeholders and minimal revisions required.
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.
Assume responsibility for novel projects, create value and innovate without defined processes. May seek guidance from Directors (i.e., SAS TAL) for complex projects.
Lead cross-functional training of relevant stakeholders.
Act as product or process Subject Matter Expert (SME) for audits/inspections.
Participate in, or lead, department and/or cross-functional initiatives.
Explore innovative ways of presenting data, preparing reports, and improving efficiencies within the programs they own.
Assist Directors in the creation, review and implementation of controlled documents and other related tools.
Management of unscheduled reports within the Aggregate Report Calendar.
Management activities within smaller Therapeutic Areas, as applicable.
Line-management of contractor positions within the team, as applicable.
Act as backup to TAL as needed (e.g., Director SAS TAL is unavailable).
Oversight of deliverables by other team members (e.g., complex reports), as needed
Qualifications / Requirements:
Education:
Bachelor’s Degree Required: Healthcare-related or Biomedical Science (11+ years industry
experience or equivalent).
Advanced Degree Preferred: Healthcare-related or Biomedical Science (8+ years industry
experience or equivalent).
Experience
Required:
Medical writing or Pharmacovigilance (PV) experience required.
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 disciplines.
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 independently influence, negotiate and communicate with both internal and external customer.
Preferred:
• Clinical experience preferred.
The anticipated base pay range for this position in the US is $137,000 to $235,750.
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.
