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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmacokinetics (PK) analysis, including non-compartmental PK analysis using Phoenix WinNonlin, and prepares high-quality documentation in compliance with regulatory guidelines. Strong communication and interpersonal skills are essential for effective collaboration within multi-disciplinary teams and client-focused project delivery.
Highest-signal resume keywords
Pharmacokinetics (PK) AnalysisPhoenix WinNonlinToxicokinetic AnalysisRegulatory Compliance (GLP, SOPs, GCP)Clinical Research Understanding
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Pharmacokinetics (PK) AnalysisToxicokinetic AnalysisData Transfer AgreementsStatistical Analysis PlansQuality-Control ReviewsLiterature SearchesNonclinical Reports PreparationProtocol ReviewSample Inventory SummariesPK Population Determinations
Soft Skills
Excellent Verbal CommunicationExcellent Written CommunicationInterpersonal SkillsClient-Focused ApproachAbility to Prioritize Workload
Tools & Technologies
Phoenix WinNonlinMicrosoft WordMicrosoft ExcelMicrosoft PowerPointInformation Technology (IT) Systems
Industry Keywords
Good Laboratory Practice (GLP)Good Clinical Practice (GCP)ICH E3 GuidanceDrug Development ProcessRegulatory Guidelines
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Gather and synthesize scientific information
- Perform PK analysis and provide high-quality documents supporting sponsors' research programs
- Serve as the PK representative, nonclinical principal investigator, or contributing scientist on assigned project teams
- Review protocols for studies of moderate complexity
- Prepare or review data transfer agreements, protocol deviation impact assessments, sample inventory summaries, and PK population determinations
- Prepare or review PK sections of statistical analysis plans
- Perform non-compartmental PK analysis using Phoenix WinNonlin
- Perform toxicokinetic analysis and prepare nonclinical reports in accordance with project/client specifications and GLP
- Interpret PK results
- Prepare or review PK sections of clinical study reports, preliminary results summaries, and standalone reports in accordance with ICH E3 guidance
- Review and assist with responses to regulatory-agency deficiency letters
- Conduct literature searches and reviews
- Perform quality-control reviews of analyses and documents
- Participate in internal and external project-team meetings
- Coordinate with internal teams to deliver documents within agreed timelines
- Contribute to risk assessment and management plans
- Conduct work in compliance with SOPs, GCP, and regulatory guidelines
- Maintain familiarity with client expectations and produce consistent analyses and documents
- Participate in quality-improvement initiatives and departmental objectives
Requirements
What you’ll need- Bachelor’s Degree in Pharmacy, Pharmacology, or relevant field (experience may be substituted for education)
- Minimum of 2 years experience as PK
- Experience in a non clinical TK setting an asset
- Experience with Phoenix WinNonlin
- Excellent verbal and written communication skills
- Professional attitude and strong interpersonal skills
- Ability to acquire and apply knowledge quickly
- Ability to work well with a multi-disciplinary team of professionals
- Client-focused approach to work
- Flexible attitude with respect to work assignments and new learning
- Ability to prioritize workload
- Understanding of clinical research, pharmacology and PK, drug development process, and applicable regulatory guidelines
- Good computer skills (Microsoft Word, Excel, and Power Point) and ability to understand and adapt to various information technology (IT) systems
- Fluency in English is an essential requirement for the position
Benefits
Comp & perks- Health/dental/vision insurance plans
- RRSP with employer match
- Paid vacation and statutory vacations
- Paid sick leave and bereavement leave
- Employee assistance and telehealth programs
- Training and development programs
- Employee orientation bonus program
- Annual performance reviews