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    Lab Research Scientist - Montréal, QC, Canada - Altasciences

    Altasciences
    Altasciences Montréal, QC, Canada

    3 weeks ago

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    Description

    At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them.

    By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences.

    The PK Scientist is responsible for gathering and synthesizing scientific information, performing pharmacokinetic (PK) and pharmacodynamics (PD) analyses, and providing high‐quality documents to support sponsors' research programs.

    Serve as the PK representative or nonclinical principal investigator or contributing scientist (as needed) on assigned project teams.
    Contribute to risk assessment and management plans (RAMPs) for assigned studies.
    Prepare and/or review data transfer agreements (DTAs).
    Prepare and/or review protocol deviation impact assessments, sample inventory summaries (SIS), and PK/PD population determinations.
    Prepare and/or review PK/PD sections of statistical analysis plans (SAPs) for studies of moderate to high complexity.
    Perform PK and PD analyses for studies of moderate to high complexity using Phoenix WinNonlin software.

    Prepare and/or review of PK/PD sections of clinical study reports (CSRs), preliminary results summaries, and standalone reports for studies of moderate to high complexity in accordance with project/client specifications and International Conference on Harmonisation (ICH) E3 guidance.

    As needed, perform toxicokinetic (TK) analysis and prepare nonclinical reports in accordance with project/client specifications and Good Laboratory Practice (GLP).

    Review and provide assistance in answering deficiency letters from regulatory agencies, as required.
    Perform literature searches/reviews as necessary to obtain background information for analyses and interpretation.

    Perform quality control (QC) review of analyses and documents prepared by other team members for completeness, accuracy, consistency, and structure.

    Actively participate in internal and external project team meetings, as required.
    Coordinate with internal team to deliver high-quality documents in accordance with agreed upon timelines.

    Conduct all work in compliance with standard operating procedures (SOPs), Good Clinical Practice (GCP), GLP, and all regulatory guidelines.

    Maintain familiarity with client expectations and produce analyses and documents consistent with these.

    Have awareness of regulatory guidelines of related authorities (Therapeutic Products Directorate [TPD], Food and Drug Administration [FDA], European Medicines Agency [EMA], etc) as well as ICH, GCP, and GLP procedures.

    May participate in departmental or interdepartmental quality improvement initiatives.
    Bachelor's Degree in Pharmacy, Pharmacology
    Flexible attitude with respect to work assignments and new learning.
    Understanding of clinical research, pharmacology, PK, TK, drug development process, and applicable regulatory guidelines.

    Good computer skills (Microsoft Word, Excel, and Power Point and Phoenix WinNonlin) and ability to understand and adapt to various information technology (IT) systems .

    Permanent, full-time position.
    Remote position.

    Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

    Health/Dental/Vision Insurance Plans
    Paid Vacation and Holidays
    Training & Development Programs
    Annual Performance Reviews

    MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH Altasciences is an equal opportunity employer committed to diversity and inclusion.

    All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation.

    Reasonable accommodations for persons with disabilities during the recruitment process are available upon request.
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