Senior Pk Research Scientist Home Based
5 days ago
**Overview**
**Senior PK Research Scientist (Home based)**
If working with a strong and robust company who is in involved in worldwide studies, who can offer you exceptional growth and development opportunities and who have a fantastic industry reputation then this could be for you
Provided you have a comfortable working office environment at home there isn't even any need to endure that dreaded commute Enjoy a walk to the local shop at lunch time, take the kids to school or even just prepare your evening meal without having to worryabout rushing home at the end of the day.
**Role responsibilities**
- Review of draft study plans/protocols and amendments and preparation of pharmacokinetics/toxicokinetic (PK/TK) analysis plans.
- Leading discussion on the design of pharmacokinetic/toxicokinetic (PK/TK) studies
- Lead trouble-shooting and problem-solving related to production work and scientific methodology for junior production analysts
- Act as a scientific resource within the department for PK/TK services and collaborate with Scientists, Study Directors, and Study Monitors and Sponsor representatives with regards to scientific matters associated with the conduct, interpretation and reportingof PK/TK data.
- Ensure that software used in PK/TK analyses is used according to its validation.
- Assist in maintaining documentation to a satisfactory standard, satisfying the requirement of GLP, as required. This includes preparing, reviewing, updating, issuing, etc. SOPs, Guidance Documents, etc. in line with Good Laboratory Practice (GLP) and regulationspublished by the FDA, EPA, JMHW and OECD.
- To maintain awareness of developments in PK within the pharmaceutical industry by attending scientific meetings, symposia or workshops and publish or present results of the research whenever possible.
**Person specification**
- PhD, Masters, Bachelor's degree with 8 or more years of relevant experience; Pharmaceutical sciences, Pharmacometrics, mathematics, statistics, or other quantitative discipline with an emphasis on Pharmacometrics and PKPD modelling; contract research organizationexperience preferred.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Demonstrated knowledge of Pharmaceutical sciences, Pharmacometrics, mathematics, statistics.
- Demonstrated ability to manage multiple projects simultaneously and deliver work in a timely manner; lead scientific discussions and provide leadership within and across disciplines.
- Ability to communicate verbally and in writing at all levels inside and outside the organization.
**Next Steps**
**Equal Opportunities**
FPSG is committed to equal opportunities regardless of gender, race, disability, sexual orientation, religion or belief and age.
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