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Job Summary
We are seeking a Research Scientist- Safety Assessment for our Study Directors- DSE at our Mattawan, MI location.
A Research Scientist – Safety Assessment serving as a study director (SD) is responsible for overseeing study conduct of preclinical efficacy and/or toxicology studies assigned by test facility management (TFM) within safety assessment; overseeing protocols/study plans; coordinating with technical teams for execution of studies, including establishing study schedules, verifying that standard operating procedures (SOPs) are available and adhered to, overseeing data recording and reporting, and verifying that regulatory requirements/expectations are met. The individual in this role interprets preclinical toxicity studies, evaluates and prepares reports from the data collected during these studies, communicates with sponsor representatives, and initiates contact with potential clients. May be involved with development of new technologies/procedures and may be required to manage departmental and procedural projects.
Essential Functions (The fundamental Duties & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed:
Function as an independent SD, working on studies/programs of moderate to difficult complexity. See detailed role and responsibilities of Study Director below:
Design, write, review and edit study plans/protocols, amendments and study schedules that define and schedule all study activities.
Oversee and coordinate study procedures.
Verify that projects are performed according to SOPs and good laboratory practices (GLP) regulations.
Write, review and edit draft or final reports that document all study related procedures and results.
Communicate with sponsors on study related business.
Job Qualifications
Qualifications (Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to:
Bachelor’s/Master’s/PhD/PharmD/DVM/MD degree or equivalent in Toxicology, Pharmacology or a related discipline; with 5 or more years of related industry experience. Meets expectations related to essential duties and responsibilities of Research Scientist 1. May represent an entry level for individual with relevant PharmD/DVM/MD degree or equivalent in Toxicology, Pharmacology or a related discipline
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Success in this role requires familiarity with: study/project costs and impact of changes, local and international regulations and GLPs as they relate to primary area of focus, study process from proposal to report, quality assurance (QA)/quality control (QC) processes, IACUC process, the SD role in animal welfare, effective communication with veterinary staff and internal/external clients in a manner that generates confidence and builds trust, and communication with technical supervisor and Scientific Manager on issues of overall project costs and its importance related to staffing and equipment issues.
Demonstrated ability to anticipate and recognize potential problems within programs and effectively communicate alternatives to clients and a meaningful fashion.
Strong communications skills, verbally and in writing at all levels inside and outside the organization.
Basic familiarity with Microsoft Office Suite.
Computer skills, commensurate with Essential Functions, including the ability to learn a validated system.
Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts; sometimes on short notice.
Ability to work under specific time constraints.
Competencies
Lead – We lead when we advocate our purpose and model our values, when we deliver innovation, when we embrace change, and when we appreciate and celebrate the great work of others.
Care – We show we care when we respect each other, our animals and the communities where we work and live, when we create a positive healthy workplace, when we are mindful of our compliance standards, and when we choose to do the right thing.
Collaborate -We collaborate when we partner with each other and promote teamwork, when we communicate clearly and effectively across the hall or around the globe, and when we welcome all forms of diversity and encourage inclusiveness.
Own – We act like owners when we hold ourselves accountable for our actions, when we respond to internal and external client needs with speed and accuracy, when we set and achieve meaningful goals, and when we strive towards continuous improvement.
Vaccine Mandate
Charles River is a U.S. Federal Contractor. As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19. Our main priority is the wellbeing, health, and safety of our people. We require proof of vaccination from all employees.
Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition ((url removed)) so that information can be provided about the accommodation process at Charles River.
About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.
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