Study Monitor, Sr. Associate Scientist/Scientist at Zoetis in Kalamazoo, Michigan

Job Description:

Role Description



Zoetis Veterinary Medicine Research and Development, Global Pharmacokinetics, Dynamics Metabolism and Safety (GPDMS) in Kalamazoo, MI is seeking a study monitor at the Sr Associate Scientist/ Scientist level. The successful candidate will support the operational needs of toxicology, pharmacokinetics, and/or target animal safety programs. This position will support work within a range of projects from early discovery through full development and post-approval for both large and small molecules, across therapeutic areas for companion animals and livestock.



Responsibilities:



• Work collaboratively with multidisciplinary teams to coordinate, monitor, and manage the logistics for non-GLP and GLP toxicology, pharmacokinetic and/or target animal safety studies internally and at contract research organizations (CROs)


• May serve as Sponsor Representative or Study Director/Investigator for in vivo studies, including authoring/co-authoring and formatting protocols, reports, and compiling supporting documents.


• Facilitate data entry/import/transfer from CROs into Zoetis databases; independently manage transfer of data and study documentation between CROs and Zoetis.


• Review, QC, and organize study results for completeness and in compliance with the study protocol, Zoetis SOPs, and applicable government regulations and guidelines.


• Maintain study files and archive studies in accordance with SOPs and regulatory requirements.


• Extract and assemble/tabulate paper and electronic data for reports and regulatory submissions.


• Position requires travel to study sites up to 10-20% of time.



Minimum skills, education, attributes:



• Bachelors with ≥5 years or Masters with ≥2 years in a biological science area, research experience in the pharmaceutical industry, or a related field.


• Understanding of scientific principles and experimental study design


• Demonstrated skills in organization of study samples, study logistics and in vivo/ bioanalytical laboratory data. GLP experience preferred.


• Experience authoring technical documents and study reports.


• Familiarity with in vivo data collection and management software.


• Advanced skills with Microsoft Office tools and overall comfort with computer systems.


• Excellent organizational and interpersonal skills as well as outstanding written and oral English communication skills.


• Ability to work in a collaborative and dynamic team environment in a global company.


• Other attributes: self-motivation, high quality standards, attention to detail, judgment, flexibility, planning, problem solving, multitasking, and adaptability.



Desirable skills, education, attributes:



• Experience in pharmaceutical drug development


• Familiarity with pharmacokinetic data collection and management software (LIMS) such as Watson


• Familiarity with in vivo, anatomic and clinical pathology data collection and management software such as Pristima


• Knowledge of requirements of various global regulatory authorities, including FDA-CVM, VICH Guidelines, and GLPs governing the conduct of preclinical safety studies for development of veterinary pharmaceuticals.


Full time


Regular


Colleague


Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.


Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.


Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at zoetiscolleagueservices@zoetis.com to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.