Associate Director, Safety Analysis Scientist, Cell Therapy jobs in United States
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Johnson & Johnson · 3 hours ago

Associate Director, Safety Analysis Scientist, Cell Therapy

Johnson & Johnson is a leader in healthcare innovation, dedicated to developing smarter and less invasive treatments. The Associate Director, Safety Analysis Scientist will provide scientific expertise in safety assessment for cell therapy products, lead safety evaluations, and collaborate with cross-functional teams to ensure regulatory compliance and support safety management activities.

Hospital & Health Care
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Comp. & Benefits
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H1B Sponsor Likelynote

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 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 Team Lead) 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 Team Lead as needed (e.g., Director SAS Team Lead is unavailable)
Oversight of deliverables by other team members (e.g., complex reports), as needed

Qualification

Medical writingPharmacovigilanceSafety evaluationsClinical experienceData analysisMicrosoft applicationsStakeholder interactionMatrix environmentPlanningPrioritizationCommunicationLeadership skills

Required

Bachelor's Degree in a Healthcare-related or Biomedical Science is required with 8-10 years industry experience or equivalent
Medical writing or Pharmacovigilance (PV) experience required
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 customers

Preferred

An Advanced Degree is preferred in healthcare-related or Biomedical Science with 6+ years industry experience or equivalent
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

Benefits

Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and 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 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

Company

Johnson & Johnson

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At Johnson & Johnson, we believe health is everything.

H1B Sponsorship

Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (48)
2024 (56)
2023 (58)
2022 (59)
2021 (44)
2020 (27)

Funding

Current Stage
Late Stage

Leadership Team

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Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
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Joaquin Duato
Chairman of the Board and Chief Executive Officer
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Company data provided by crunchbase