Johnson & Johnson Innovative Medicine · 15 hours ago
Associate Director, Safety Analysis Scientist
Titusville, NJ
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$137K/yr - $236K/yr
8+ years expJohnson & Johnson is a leader in healthcare innovation dedicated to developing treatments and solutions for complex diseases. They are seeking an Associate Director, Safety Analysis Scientist who will provide scientific expertise and lead safety assessments for products, collaborating with cross-functional teams to ensure compliance and safety evaluations.
Pharmaceuticals
Responsibilities
Leading safety evaluations including strategy discussions, collaborating with Therapeutic Area Safety Head (TASH)/MSO and other partners as necessary, data retrieval, data analysis, report writing, and report revision
Ensuring high quality safety evaluations and reports with minimal comments from partners and minimal revisions required
Providing input and review of 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, if applicable and form a safety position across Global Medical Safety (GMS) which can be used for aggregate safety reports
Providing support for Health Authority interactions regarding safety and risk management, both written and verbal
Assuming responsibility for novel projects, bringing value and innovation without defined processes. May seek guidance from Directors (i.e., SAS TAL) for complex projects
Leading cross-functional training of relevant partners
Acting as product or process Subject Matter Expert (SME) for audits/inspections
Participating in, or leading, department and/or cross-functional initiatives
Exploring innovative ways of presenting data, preparing reports, and improving efficiencies within the programs they own
Assisting Directors in the creation, review and implementation of controlled documents and other related tools
Managing unscheduled reports within the Aggregate Report Calendar
Managing activities within smaller Therapeutic Areas, as applicable
Line-management of contractor positions within the team, as applicable
Acting as backup to TAL as needed (e.g., Director SAS TAL is unavailable)
Qualification
Required
A minimum of a Bachelor's degree in Biomedical Science or a Healthcare related field is required. An advanced degree is preferred
8+ years of relevant experience is required
Medical writing or Pharmacovigilance (PV) experience is required
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 fields 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 plan work to meet deadlines and effectively balance multiple priorities is required
Preferred
Ability to effectively interact with team members, including business partners
Ability to work in a matrix environment, proven leadership skills
Proficiency in Microsoft applications (e.g., Word, Excel, and PowerPoint)
Ability to independently influence, negotiate and communicate with both internal and external customers
Clinical experience
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
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 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
Company
Johnson & Johnson Innovative Medicine
Johnson and Johnson Innovative Medicine focuses on developing medical solutions for some of the challenging diseases and medical conditions.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Molly Perkins
VP, Head of Cell & Genetic Medicines Discovery
Recent News
2025-08-14
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