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.
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.
#LI-HybridRequired Skills: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)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
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 period10 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
