Lachman Consultants, the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries, is seeking per diem Toxicologists.
Qualifications / Responsibilities include:
- Strong knowledge of the Drug Development process (pharmaceutical or biotechnology)
- Strong knowledge of global regulatory pharmaceutical and food regulations
- Delivery of regulatory and scientific advice on nonclinical product development programs
- Deep scientific knowledge of toxicology
- Development / implementation of toxicology strategies
- Risk management
- Design, initiation, and implementation of nonclinical investigative toxicology studies
- Nonclinical testing for acute and chronic studies
- Nonclinical effect troubleshooting
- Preparation of nonclinical summaries for INDs, NDAs, and PLAs
- Environmental assessments for INDs and NDAs
- Contract laboratory selection
- Test protocol review and development
- Dossier analysis
- Evaluation of GLP compliance
- Regulatory document preparation
- Toxicology safety assessments
- Preparation of nonclinical toxicology e-CTD components of submissions (e.g., IND, NDA, BLA) and other related documents
Educational requirements include:
- P.h.D. in Toxicology required; DABT preferred and 10 years industry, government or academic experience.
For four decades, Lachman Consultants has been the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries. With its strong and extensive cadre of consultant specialists and an unparalleled management team, its Compliance, Science & Technology, and Regulatory Practices provide the most expert counsel and array of services available. Lachman Consultants is proud of its tradition of supporting industry efforts to develop and ensure safe, effective and high-quality medical products. It remains committed to helping the industry anticipate and address its challenges through the development and implementation of practical, sustainable and cost-effective solutions based on the integration of scientific principles, evolving regulatory expectations, and technology.