Senior Scientist, Drug Safety & Metabolism - Hybrid

MSD; Rahway (NJ); Hybrid; USD 106,000 - 167,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ seeks a Senior Scientist for Drug Safety and Metabolism to manage GLP in vivo safety studies and data packages for regulatory submissions.

You will coordinate CROs, oversee data quality, and contribute to submission-ready reports for global health authorities, including the US FDA. The role requires strong communication, collaboration with study leads, and a focus on data integrity, regulatory guidelines, and timely study execution.

Qualifications

• Bachelor of Science with at least four (4) years of experience in veterinary sciences, toxicology/pharmacology, pharmacokinetics, biology, chemistry, biochemistry, or equivalent.

Responsibilities

• Assist study leads to ensure all necessary actions are taken for a successful study outcome and study timelines are met.
• Lead generation of raw data package and subsequent submission-ready report(s)/package.
• Participate in the creation of study protocols and data capture forms.
• Work with the study lead to identify potential CROs to conduct study.
• Assist the study lead in the preparation of study contracts, as appropriate.
• Conduct and/or participate in pre-study meeting(s) or discussions which involve protocol review/training and study monitoring visits, as appropriate, to ensure CRO compliance with the protocol and relevant regulations/guidelines.
• Collect, review, and monitor study documentation.
• Prepare monitoring visit reports and provide them to study lead (if monitored by incumbent).
• Communicate regularly with the study lead and assist study lead in tracking all study-related activities.
• Ensure high quality data by thorough monitoring/reviewing of raw data and study documentation.
• In addition to review of raw data, review study phase reports and final reports for completeness against the study protocol, amendments, deviations, SOPs, OECD, and GLP guidelines.
• Assist study lead in reviewing and finalizing study reports.
• Assist in the preparation of the study package for regulatory submission to current quality/data integrity standards.
• Work with the study lead to transfer the study package to the archivist or other document depositor.

Skills

Automated Liquid Handling Systems

Bioanalytical Method Development

Bioanalytical Techniques

Clinical Judgment

Data Analysis

Experimentation

Flow Cytometry

Immunohistochemistry

Research Proposal Development

Scientific Writing

Teamwork

Tissue Culture Techniques

Education

Bachelor of Science

Tools

Microsoft Word

Excel

PowerPoint

SharePoint

Job description

Merck & Co., Inc. in Rahway, NJ seeks a Senior Scientist for Drug Safety and Metabolism to manage GLP in vivo safety studies and data packages for regulatory submissions.

You will coordinate CROs, oversee data quality, and contribute to submission-ready reports for global health authorities, including the US FDA. The role requires strong communication, collaboration with study leads, and a focus on data integrity, regulatory guidelines, and timely study execution.