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Lead in ensuring product compliance and patient safety through cutting-edge toxicology strategies. Define, create, and execute non-clinical safety and efficacy assessments essential for the development of groundbreaking medical devices as per ISO 10993 series of standards and pharmaceutical packaging systems as per US pharmacopeia and other ministries of health as required. Apply expertise in pre-clinical science and toxicological principles to support new product development (NPD), sustain product organization (SPO), and drive manufacturing improvement projects (MIP). Serve as the primary point of contact for Pre-Clinical Toxicology within the assigned Business Segment or Division.
Job Responsibility:
Provide technical and strategic input to project teams
Take the lead in authoring pre-clinical sciences and toxicology deliverables, including non-clinical testing plans and toxicological risk assessments
Plan and manage complex projects
Assess technical and scientific information, identify deficiencies, and design innovative solutions to mitigate risks
Support innovation initiatives by providing technical direction
Participate in standards organizations and regulatory committees
Work closely with R&D, Clinical, Medical Affairs, Regulatory Affairs, Quality, Manufacturing, and Environmental Health and Safety teams
Articulate the Pre-Clinical Toxicology vision, goals, and performance to project teams
Establish and nurture professional networks both internally and externally
Requirements:
BS with 8+ years, MS with 6+ years, or PhD with 2+ years of relevant experience in R&D and/or GLP environments
Medical Device experience strongly preferred
Solid understanding of national and international non-clinical safety and biological evaluation regulations, including Good Laboratory Practices (GLP)
Direct experience working with regulatory bodies such as the US-FDA, EU Notified Bodies, and other national or international reviewers
A strong track record of presenting at scientific conferences and authoring/co-authoring published articles in peer-reviewed journals
Demonstrated ability to advance new product development projects and provide innovative non-clinical solutions for pharmaceutical and medical device challenges
Experience in a GLP and/or R&D environment, with a solid understanding of project management principles
What we offer:
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service