Senior Scientist Drug Safety & Metabolism

Job description

Job Description MAJOR ACTIVITIES AND RESPONSIBILITIES: (Brief description of major activities and the scope of the job e.g. supervisory responsibilities and scientific decision making and authority, e.g. generating and evaluating data). The Senior Scientist, Drug Safety and Metabolism, is part of Global Preclinical Development team in Rahway, NJ. The ideal candidate will participate as a member of multiple study teams working under the supervision/leadership of the assigned study lead in Preclinical Development (PCD)-US. He/She will be required to assist in the design, coordination, monitoring, and reporting of in vivo safety studies for companion animals and/or residue studies for livestock veterinary small molecule pharmaceuticals to obtain regulatory approval from various global health authorities. The position requires study conduct in accordance with Good Laboratory Practice (GLP) regulations and applicable regulatory guidance documents. Additional aspects incumbent to the role include travel to CROs to observe critical phases,  Quality Control (QC) review, raw data/XML file generation/preparation, and generation of submission-ready packages to global health authorities, especially the US FDA. Overall Leadership: Familiarity with and ability to work under applicable departmental SOPs, regulations, and guidelines (VICH/GLP [21CFR58 or OECD]). 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. Study Planning: 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. Study Conduct: 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. Data Management: Ensure high quality data by thorough monitoring/reviewing of raw data and study documentation. Specifically, develop expertise needed to address CVM’s data quality/integrity component as regards submissions, via training on review of raw data in line with CVM’s requirements, and be the point person to organize and assemble global and US-only submissions for PCD. 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. Study Reporting: 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. Education Minimum Requirement: Bachelor of Science with at least four (4) years of experience in veterinary sciences, toxicology/pharmacology, pharmacokinetics, biology, chemistry, biochemistry, or equivalent. Required Experience and Skills: Recent (within the last 3 years) experience conducting and/or monitoring in vivo preclinical safety studies to support registration of veterinary/companion animal pharmaceuticals in an industrial setting or CRO. Experience preparing and/or obtaining solid scientific reports from CROs. Experience with Good Laboratory Practices (GLPs). Excellent verbal and written communication skills required, with good attention to detail; Team-player with strong inter-personal skills. Proven ability to multi-task, manage competing priorities, deliver work product within established timelines, and adapt to rapidly shifting priorities. Knowledge of standard computer software applications for general office work (e.g. Microsoft Word, Excel, PowerPoint, SharePoint, etc.). Preferred Experience and Skills: A working understanding of domestic and international regulations and guidance that govern veterinary drug development for companion and food animals. Knowledge of electronic data capture systems and submission package preparation. Experience in conducting, monitoring, reviewing and/or summarizing residue and safety studies to support domestic and international registration of veterinary pharmaceuticals. Required Skills: Automated Liquid Handling Systems, Bioanalytical Method Development, Bioanalytical Techniques, Clinical Judgment, Data Analysis, Experimentation, Flow Cytometry, Immunohistochemistry (IHC), Research Proposal Development, Scientific Writing, Teamwork, Tissue Culture Techniques Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The primary location for this posting is: USA - New Jersey - Rahway Where required by law, the compensation range for this role is provided below. The salary range for the primary location of this role is: $106,200.00 - $167,200.00 This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits. Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location. Additional location(s) Compensat