Baxter is looking to ensure product compliance and patient safety through cutting-edge toxicology strategies for medical devices and pharmaceutical packaging systems.
Requirements
- A BS with 13+ years, MS with 10+ years, or PhD with 4 + years of relevant experience in R&D and/or GLP environments.
- 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.
- Medical Device experience strongly preferred.
Responsibilities
- Provide technical and strategic input to project teams, ensuring compliance with Baxter and external standards while driving business objectives.
- Take the lead in authoring pre-clinical sciences and toxicology deliverables, including non-clinical testing plans and toxicological risk assessments, to support global programs.
- Plan and manage complex projects, prioritizing workloads and meeting major organizational objectives in collaboration with senior management.
- Assess technical and scientific information, identify deficiencies, and design innovative solutions to mitigate risks.
- Support innovation initiatives by providing technical direction and ensuring the quality of deliverables that integrate state-of-the-science theory with practical approaches.
- Participate in standards organizations and regulatory committees to influence emerging regulations based on sound scientific principles.
- Work closely with R&D, Clinical, Medical Affairs, Regulatory Affairs, Quality, Manufacturing, and Environmental Health and Safety teams to support various projects and initiatives.
Other
- Lead with Expertise
- Innovate and Author
- Project Management
- Evaluate and Remediate
- Drive Innovation
