Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Responsible for defining/designing, conducting and/or technical support of target animal safety, pharmacokinetic, metabolism, and residue studies and human safety programs to support world-wide registrations of veterinary pharmaceuticals.
This position is part of Drug Safety and Metabolism, Global Preclinical Development, based in Madison, New Jersey. The ideal candidate will:
- Define preclinical programs needed for registration and marketing of companion and food animal pharmaceuticals.
- Target species include: dogs, cats, horses, beef and dairy cattle, chickens, pigs, sheep, goats and fish.
- Human Safety: Programs may include a range of studies, such as toxicology, metabolism, and residue depletion studies, and exposure/risk assessment in support of user/handler safety.
- Target Animal Safety: Programs may include dose tolerance / margin of safety studies, injection site irritation, and reproduction safety studies.
- Special Studies or Issues: May design and conduct special studies or literature reviews to address specific safety issues (excipients, impurities, leachables/extractables, etc.).
- Study programs may require: Study design/protocol development, placing studies at contract research organizations (CROs), study monitoring, data/report review, and problem issue resolution. Key to the support of study programs is to ensure data accuracy, integrity, and proper data interpretation and discussion as well as to inform internal customers of study progress and any critical issues.
- Interact with regulatory agencies to address concerns with products currently in development or marketed products, including preparation of expert reports, position papers, formal presentations, etc., for regulatory agencies.
- Maintain technical and professional expertise by staying abreast of developments in the field and sharing that information with the appropriate areas of Intervet Inc. (d/b/a Merck Animal Health).
- Maintain knowledge of regulatory and compliance requirements for areas of responsibility.
- Adhere to the policies and procedures in the areas of Good Laboratory Practice, business conduct, and general safety.
Education Minimum Requirement:
- Ph.D or D.V.M. with at least four (4) years of experience in Preclinical toxicology/pharmacology, biology, chemistry, biochemistry, or equivalent combination of education, training and relevant experience.
Required Experience and Skills:
- A working understanding of domestic and international veterinary drug development for companion and food animals
- Proven experience in designing developmental and regulatory approaches for companion and food animal drugs
- Experience conducting, monitoring, reviewing and/or summarizing preclinical studies to support registration of veterinary/companion animal pharmaceuticals
- A working knowledge of placing, monitoring and obtaining solid scientific products or reports from CROs
- A working knowledge of the Good Laboratory Practices (GLP's)
- Excellent verbal and written communication skills required, with good attention to details; Team-player with strong inter-personal skills
- Knowledge of standard computer software applications for general office work (word processing, presentation, and spreadsheet)
Preferred Experience and Skills:
- A working understanding of domestic and international veterinary drug development and various agribusiness practices affecting companion and food animals, including aquaculture, is desirable.
- Experience in environmental toxicology and/or environmental exposure/risk assessments is also desirable but not mandatory.
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Visa sponsorship is not available for this position.
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