Job Description

Job Description

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
  

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

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected US salary range:
$104,200.00 - $163,900.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here .

San Francisco Residents Only: -We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: -We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully-
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. -No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.-

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
N/A

Job Posting End Date:
04/21/2025
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R344770

Job Tags

Holiday work, Full time, For contractors, Local area, Remote job, Relocation, Visa sponsorship, Flexible hours, Shift work, 3 days per week,

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