Pharma Medica Research (PMRI) Inc. is a Contract Research Organization that strives for innovation and original solutions in a highly regulated and competitive industry. If your career goals align with innovation and original thinking you will be the perfect candidate to be part of an inclusive, adaptable, and forward-thinking organization. Our reputation for delivering high quality research is outstanding. At PMRI we are committed to making a difference in healthcare and people's lives. Come join our team! We are currently looking for aPharmacokinetic Scientist (PK Scientist)to join our team.
ThePK Scientistperforms pharmacokinetic/pharmacodynamic analyses of data generated through clinical studies; assist in the design of pharmacokinetic and comparative bioavailability studies; review study protocols, provide support in statistical analyses, as well as prepare/review study reports. This position reports to the Manager, PK and/or designate.
Responsibilities:
- Perform pharmacokinetic analysis of data generated in Phase I-IV clinical studies.
- Perform pharmacokinetic and statistical analysis of data generated through comparative bioavailability trials.
- Perform pharmacokinetic and/or pharmacodynamic modeling as required.
- Prepare study designs.
- Review study protocols and study reports for scientific content, data accuracy and compliance with Canadian, American and European guidelines.
- Ensure timely delivery of accurate study reports to Pharma Medica Research Inc. (PMRI) clients.
- Assist in preparation and review of necessary regulatory documentation (e.g. CTA).
- Provide scientific support to other departments within PMRI.
- Responsible for acquiring and maintaining knowledge of national and international guidelines.
- Assist in the review of study documentation and in the preparation of an action plan for regulatory inspections.
- Responsible for developing, writing, implementing and maintaining Standard Operating Procedures (SOPs) related to pharmacokinetics, biometrics and report writing activities in co-operation with Sr. Management.
- Attendance at selected scientific and commercial meetings and exhibitions where you will assist PMRI personnel in the marketing of PMRI services.
- Other duties as assigned.
Qualifications:
- M.Sc. in Pharmacokinetics and experience in design and conduct of bioavailability and bioequivalence studies.
- User-level knowledge of pharmacokinetic software (e.g. WinNonlin , Kinetica , etc.) and statistical software (SAS ).
- 2-3 years related experience
- Good communication skills including good English verbal and written skills
- Good interpersonal skills
- Ability to work both independently and as a team member
We offer:
- Competitive compensation plan
- A benefit plan that is fully paid for by PMRI, including healthcare, dentalcare, vision care, LTD, Life Insurance, AD\&D, along with a Health Spending and Wellness Spending Accounts and a voluntary RRSP Contribution Plan
- Opportunities for advancement and career progression
- A generous Employee Milestones Awards Program
- Corporate Discounts Program
- Learning Support Programs
- Friendly atmosphere, culture of learning
Please note all applications must be eligible to work within Canada.
PMRI is an Equal Opportunity Employer; promoting accessibility and inclusivity at work and offering accommodation for applicants as required and requested.
We thank all applicants for their interest; however, only those selected to proceed in the interview process will be contacted.
