Regulatory Testing Coordinator or Specialist jobs in United States
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Physicians Committee for Responsible Medicine · 2 months ago

Regulatory Testing Coordinator or Specialist

The Physicians Committee for Responsible Medicine is dedicated to advancing ethical, human-relevant approaches in toxicology. The Regulatory Testing Specialist will support this mission by developing and promoting in vitro and computational methods for chemical safety assessment and facilitating their regulatory acceptance.

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Responsibilities

Advance the replacement of animal tests in regulatory toxicology programs:
Drive the development, evaluation, and implementation of human-relevant in vitro and computational methods across multiple toxicological endpoints
Draft, review, and coordinate scientific and regulatory documents, including Test Guidelines, Integrated Approaches to Testing and Assessment (IATAs), and Detailed Review Papers
Monitor and analyze activities at the OECD, EPA, FDA, EMA, and other regulatory bodies, providing scientific and strategic input to promote adoption of nonanimal approaches
Lead data analysis, scientific and regulatory writing, and collaborative project work to advance nonanimal methods regulatory programs
Design and execute workshops, trainings, and stakeholder meetings with regulators, industry, and academic partners
Collaborate with cross-sector partners to identify data gaps, propose innovative approaches, and advance regulatory acceptance of in vitro and computational methods
Communicate the benefits of nonanimal test methods to lay and scientific audiences:
Author a variety of works ranging from peer-reviewed manuscripts to breaking research synopses to newsletter articles or blog posts
Serve as spokesperson to lay and trade press with media training and guidance as needed
Assist communications team in developing traditional and social media packages
Submit abstracts and present research or policy positions
Keep up to date with scientific literature as needed to cultivate expert status in the development and implementation of various nonanimal approaches

Qualification

Vitro toxicologyComputational methodsRegulatory frameworksScientific writingCollaborationPassion for missionCommunication skillsCritical thinkingProblem-solving

Required

All candidates must be legally authorized to work in the United States
Education: Required: Master's degree in Toxicology, Pharmacology, Biomedical Sciences, Computational Biology, or a related field
Work Experience: Required: A minimum of 3 years of total work experience, including a minimum of 2 years in toxicology, pharmacology, or regulatory science, with exposure to in vitro or computational methods
Additional Qualities: Required: Writing & Communication: Strong writing and communication skills, with the ability to clearly convey scientific and regulatory concepts to broad audiences
Regulatory Understanding: Familiarity with U.S. and international regulatory frameworks (e.g., EPA, FDA, EMA, OECD)
Scientific Expertise: Hands-on experience with in vitro toxicology assays (e.g., cell-based models, tissue-engineered systems, high-content screening) and/or computational methods (QSAR, read-across, cheminformatics, IVIVE, PBPK)
Passion for Our Mission: Deep commitment to advancing human-relevant science and replacing animal testing through innovative toxicology methods and regulatory engagement

Preferred

Education: Preferred: Ph.D. in Toxicology, Computational Biology, Cheminformatics, or a related discipline, with research experience in in vitro toxicology, computational modeling (QSAR, read-across, IVIVE, PBPK), mechanistic assays, and regulatory toxicology
Work Experience: Preferred: A minimum of 10 years of total work experience (including graduate or postdoctoral research), with a minimum of 5 years applying nonanimal methods and engaging with regulatory programs such as OECD, EPA, or FDA
Additional Qualities: Preferred: Scientific & Regulatory Writing: Exceptional writing skills with demonstrated ability to draft scientific manuscripts, regulatory and guidance documents (e.g., IATAs, DRPs, Test Guidelines, white papers)
Regulatory Knowledge: Strong understanding of national and international regulatory frameworks (e.g., EPA, FDA, EMA, OECD)
Innovation & Collaboration: Demonstrated capacity for critical thinking, problem-solving, and cross-sector collaboration

Benefits

Health insurance with 100% of the deductible and 75% of the premium paid by the Physicians Committee for full-time employees.
Dental insurance available at a group discount.
403(b) retirement savings plan with matching contribution of $0.50 per dollar up to 6% of salary.
Flexible spending accounts for healthcare and dependent care expenses which allows paying for some expenses on a pre-tax basis.
Pre-tax purchase of Metro fare.
Long-term disability income protection insurance and life insurance fully paid for by the Physicians Committee.
20 days of paid time off to start plus 14 paid holidays.

Company

Physicians Committee for Responsible Medicine

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Physicians Committee for Responsible Medicine is nonprofit organization that promotes preventive medicine, conducts clinical research, etc.