Senior Scientist Drug Safety & Metabolism

MSD•Rahway, NJ

2d•$106,200 - $167,200•Hybrid

About The Position

The Senior Scientist, Drug Safety and Metabolism, is part of the Global Preclinical Development team in Rahway, New Jersey. The role participates in multiple study teams under the supervision and leadership of assigned study leads in Preclinical Development (PCD)-US. The scientist assists in designing, coordinating, monitoring, and reporting in vivo safety studies for companion animals and/or residue studies for livestock veterinary small-molecule pharmaceuticals to support regulatory approval by global health authorities. Studies must be conducted in accordance with Good Laboratory Practice (GLP) regulations and applicable regulatory guidance. The role also includes travel to contract research organizations (CROs) to observe critical study phases, quality-control review, raw-data and XML-file generation or preparation, and preparation of submission-ready packages for global health authorities, especially the US FDA. The position works under applicable departmental SOPs, regulations, and guidelines, including VICH/GLP (21 CFR 58 or OECD).

Requirements

Bachelor of Science and at least four years of experience in veterinary sciences, toxicology/pharmacology, pharmacokinetics, biology, chemistry, biochemistry, or an equivalent field.
Recent experience, within the last three years, conducting and/or monitoring in vivo preclinical safety studies supporting registration of veterinary or companion-animal pharmaceuticals in an industrial setting or CRO.
Experience preparing and/or obtaining sound scientific reports from CROs.
Experience with Good Laboratory Practices (GLPs).
Excellent verbal and written communication skills, attention to detail, and strong interpersonal and teamwork skills.
Ability to multitask, manage competing priorities, deliver work within established timelines, and adapt to rapidly shifting priorities.
Knowledge of standard office computer applications, such as Microsoft Word, Excel, PowerPoint, and SharePoint.
Required skills listed: Automated Liquid Handling Systems, Bioanalytical Method Development, Bioanalytical Techniques, Clinical Judgment, Data Analysis, Experimentation, Flow Cytometry, Immunohistochemistry (IHC), Research Proposal Development, Scientific Writing, Teamwork, and Tissue Culture Techniques.

Nice To Haves

Working understanding of domestic and international regulations and guidance governing veterinary drug development for companion and food animals.
Knowledge of electronic data-capture systems and submission-package preparation.
Experience conducting, monitoring, reviewing, and/or summarizing residue and safety studies supporting domestic and international registration of veterinary pharmaceuticals.

Responsibilities

Assist study leads in taking the actions necessary for successful study outcomes and meeting study timelines.
Lead generation of raw-data packages and subsequent submission-ready reports or packages.
Participate in creating study protocols and data-capture forms.
Work with study leads to identify potential CROs and assist with preparing study contracts as appropriate.
Participate in pre-study meetings or discussions involving protocol review and training, and in study-monitoring visits as appropriate, to help ensure CRO compliance with protocols and applicable regulations and guidelines.
Collect, review, and monitor study documentation.
Prepare monitoring-visit reports and provide them to the study lead when monitoring is performed by the incumbent.
Communicate regularly with the study lead and help track study-related activities.
Monitor and review raw data and study documentation to support data quality and integrity, including organizing and assembling global and US-only PCD submissions.
Review study-phase and final reports for completeness against protocols, amendments, deviations, SOPs, OECD guidance, and GLP guidelines.
Assist the study lead in reviewing and finalizing study reports.
Assist in preparing study packages for regulatory submission to current quality and data-integrity standards.
Work with the study lead to transfer study packages to the archivist or another document depositor.