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Associate Principle Scientist, Drug Safety & Metabolism Job

Job Details

Associate Principle Scientist, Drug Safety & Metabolism-PRE000565

Description

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 environmental toxicology and fate studies and/or environmental risk assessments to support world-wide registrations of veterinary pharmaceuticals.

This position is part of Drug Safety and Metabolism, Global Preclinical Development, based in New Jersey.

- Steer preclinical development of pharma projects with regard to ecotoxicological requirements. Ensure that any deviations from the anticipated product profile arising from ecotoxicological properties are promptly identified, and suitable strategies to address relevant issues are provided.

- Support research projects by providing ecotoxicological expertise and ensure that decisions within projects are made based on sound ecotoxicological science/assessments.

- Identify and provide strategies to meet critical objectives and issues for acceleration or termination of projects with respect to ecotoxicology.

- Steer defense of pharma products with regard to ecotoxicological requirements.

- Establish and maintain contacts with external experts and CROs to provide required capacities and expertise. Serve as Study Monitor, or occasionally Study Director, for any out-sourced work. Specifically, plan studies with relevant CROs, supervise conduct of studies, and ensure compliance with study protocols. Ensure quality of investigator’s work/work product.

- Ensure planned ecotoxicology study program(s) meet current legal and regulatory requirements (GLP, EU & FDA).

- Ensure correct scientific analysis of data and validity of study and expert reports within the area of responsibility (environmental risk assessment).

- Ensure efficient use of resources by setting priorities (in agreement with line function & Project Manager).

- Ensure availability of regular reports concerning results, costs, budgets and provide updates (line function and Project Manager) routinely.

- Ensure an overall high quality of development work and ecotoxicological support through routine literature searches, participation in scientific conferences, and contacts with relevant scientific opinion leaders.

- Sharing of knowledge: Guide, motivate and assist in the training and development of colleagues in environmental toxicology/risk assessment, as needed.

- Adhere to the policies and procedures in the areas of Good Laboratory Practice, business conduct, and general safety.

Qualifications

Education Minimum Requirement:

- Ph.D or D.V.M.

Required Experience and Skills:

- Do you have a minimum of five (5) years of industry experience in biology, chemistry, biochemistry, or related area.

- A working understanding of domestic and international veterinary drug development for companion and food animals

- Experience in conducting, monitoring, reviewing and/or summarizing environmental toxicology and fate studies to support domestic and international registration of pharmaceuticals, specifically for subsequent environmental risk assessments

- Experience in conducting environmental risk assessments including modeling of the environmental exposure and evaluating effects

- Experience in designing global developmental and regulatory approaches to address environmental concerns associated with marketed companion and food animal drugs (product defense)

- Working knowledge of Good Laboratory Practices (GLPs)

- Knowledge of standard computer software applications for general office work (word processing, presentation, and spreadsheet)

- Excellent verbal and written communication skills required, with good attention to details; Team player with strong inter-personal skills

- Domestic and international travel required

Preferred Experience and Skills:

- Experience in environmental safety/risk assessment, environmental toxicology study design/conduct/interpretation, and environmental exposure modeling is mandatory.

- Experience in PK and metabolism in laboratory and food safety animals as well as mammalian toxicology is also desired.

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​



Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Preclinical Dev Generic

Job Title:Assoc Prin. Scientist, Preclinical Dev.

Primary Location: NA-US-NJ-Madison

Employee Status: Regular

Travel: Yes, 15 % of the Time

Number of Openings: 1

Company Trade Name:Merck

Company

Our vision is to make a difference in the lives of people globally through our innovative medicines, vaccines, biologic therapies, consumer health and animal products. We aspire to be the best healthcare company in the world and are dedicated to providing leading innovations and solutions for tomorrow.

We have made it our mission to provide innovative, distinctive products and services that save and improve lives, satisfy customer needs and to be recognized as a great place to work

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