PK Associate I
3.
2 20 hours ago Full Job Description For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies.
When you join our family, you will have a significant impact on the health and well-being of people across the globe.
Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform.
In return, we'll help you build a career that you can feel passionate about.
IMPORTANT:
In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.
Please make sure work history and education are added correctly.
Job Summary REMOTE 1st Shift Mon-Fri We are seeking an experienced PK Associate I for a remote opportunity supporting our Safety Assessment site located in Mattawan, MI.
A PK Associate I is responsible for:
data coordination including communication with Study Directors and/or Scientists, QC/peer review of TK analysis and reports to include (but not limited to) ensuring analysis was performed according to SOPs, protocol, GLPs (as applicable), and good scientific practices, coordination and participation in addressing sponsor comments to TK reports, and other miscellaneous coordination and/or scientific tasks.
Essential Functions:
(The fundamental Duties & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed:
Familiarity with PK platform tools (access and use).
Assist in the review of draft study plans/protocols and amendments and in the preparation of pharmacokinetics/toxicokinetic (PK/TK) analysis plans.
Assist tabulating data and being involved in preliminary data analysis, summary report and assist in the preparation of text of draft reports.
Participate in the review of PK/TK reports and data whenever applicable.
Communicating, when needed, with Study Director/Sponsor/Individual Scientist/Principal Investigator after discussion with the scientist(s) whenever applicable.
Familiar with the scheduling process and deliver as per schedule.
Familiar with standard operating procedures (SOPs), Good Laboratory Practice (GLP) and regulations published by the FDA, EPA, JMHW and OECD.
To undertake other duties as might be reasonably requested from time to time and to ensure that the work is conducted in a co-operative and flexible manner.
To participate in overtime as reasonably required to ensure the smooth running of the department.
To maintain awareness of developments in PK within the pharmaceutical industry, including software such as WinNonlin and other parameter estimation software packages.
Job Qualifications Qualifications (Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to:
Bachelors/Master's degree with zero to one year of relevant experience; Pharmaceutical sciences, Pharmacometrics, mathematics, statistics, or other quantitative discipline with an emphasis on Pharmacometrics and PKPD modeling; contract research organization experience preferred.
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Demonstrated ability to manage multiple projects simultaneously and deliver work in a timely manner.
Ability to communicate 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.
IMPORTANT:
A resume is required to be considered for this position.
If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV.
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.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
2 20 hours ago Full Job Description For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies.
When you join our family, you will have a significant impact on the health and well-being of people across the globe.
Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform.
In return, we'll help you build a career that you can feel passionate about.
IMPORTANT:
In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.
Please make sure work history and education are added correctly.
Job Summary REMOTE 1st Shift Mon-Fri We are seeking an experienced PK Associate I for a remote opportunity supporting our Safety Assessment site located in Mattawan, MI.
A PK Associate I is responsible for:
data coordination including communication with Study Directors and/or Scientists, QC/peer review of TK analysis and reports to include (but not limited to) ensuring analysis was performed according to SOPs, protocol, GLPs (as applicable), and good scientific practices, coordination and participation in addressing sponsor comments to TK reports, and other miscellaneous coordination and/or scientific tasks.
Essential Functions:
(The fundamental Duties & Responsibilities of the role (products and services provided/results accomplished) include, but are not limited to, those listed:
Familiarity with PK platform tools (access and use).
Assist in the review of draft study plans/protocols and amendments and in the preparation of pharmacokinetics/toxicokinetic (PK/TK) analysis plans.
Assist tabulating data and being involved in preliminary data analysis, summary report and assist in the preparation of text of draft reports.
Participate in the review of PK/TK reports and data whenever applicable.
Communicating, when needed, with Study Director/Sponsor/Individual Scientist/Principal Investigator after discussion with the scientist(s) whenever applicable.
Familiar with the scheduling process and deliver as per schedule.
Familiar with standard operating procedures (SOPs), Good Laboratory Practice (GLP) and regulations published by the FDA, EPA, JMHW and OECD.
To undertake other duties as might be reasonably requested from time to time and to ensure that the work is conducted in a co-operative and flexible manner.
To participate in overtime as reasonably required to ensure the smooth running of the department.
To maintain awareness of developments in PK within the pharmaceutical industry, including software such as WinNonlin and other parameter estimation software packages.
Job Qualifications Qualifications (Knowledge, Experience, Skills and Abilities required to accomplish the essential functions) include but are not limited to:
Bachelors/Master's degree with zero to one year of relevant experience; Pharmaceutical sciences, Pharmacometrics, mathematics, statistics, or other quantitative discipline with an emphasis on Pharmacometrics and PKPD modeling; contract research organization experience preferred.
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Demonstrated ability to manage multiple projects simultaneously and deliver work in a timely manner.
Ability to communicate 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.
IMPORTANT:
A resume is required to be considered for this position.
If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV.
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.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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