Associate Director, Safety Analysis Scientist jobs in United States
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Johnson & Johnson · 4 hours ago

Associate Director, Safety Analysis Scientist

Johnson & Johnson is a leader in healthcare innovation, seeking an Associate Director, Safety Analysis Scientist. This role involves providing scientific expertise and leading safety assessments for products, collaborating with cross-functional teams to ensure regulatory compliance and support safety-related decisions.

Hospital & Health Care
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Comp. & Benefits
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H1B Sponsor Likelynote

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

Medical writingPharmacovigilanceSafety data analysisBiomedical ScienceClinical experienceMicrosoft applicationsInteractCommunicationLeadership skillsNegotiate

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

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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