Report Writer Job Vacancy in Ann Arbor Pharmacometrics Group Ann Arbor, MI 48108 – Latest Jobs in Ann Arbor, MI 48108

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Company Name :
Ann Arbor Pharmacometrics Group
Location : Ann Arbor, MI 48108
Position : Report Writer

Job Description : The Ann Arbor Pharmacometrics Group is a functional service provider specializing in model-based drug development consulting for the pharmaceutical industry.Founded in 2007 by three former Pfizer employees, A2PG works to promote leveraging information across statistics as well as clinical and pharmacokinetic/pharmacodynamic disciplines through the application of models and clinical trial simulation techniques in order to enhance drug development strategies and decision-making. To date, A2PG has worked with over sixty pharmaceutical and drug development companies.A2PG is now seeking a report writer with a background or interest in clinical research and medical writing to join our team.Position Overview:· A2PG report writers work with pharmacometricians to prepare analysis plans, modeling and simulation reports and regulatory submission documents for our clients’ drug development programs.Specific Responsibilities:· Prepare analysis plans and reports (internal reports for client as well as submission-ready reports) of modeling and simulation results.· Facilitate the report review and approval process.· Coordinate activities for the quality control (QC) of results against original source documents.· Comply with 21CFR11 regulations to maintain an audit trail of all reported results.· Maintain working knowledge of regulatory agency guidelines and requirements.· Prepare regulatory response documents as requested.· Participate with client and A2PG pharmacometricians in the preparation of manuscripts for journal submissions and/or posters for presentation at professional meetings.Qualifications:· Bachelor’s degree or higher in pharmacology, biology, health science, a related field or commensurate experience required.Benefits:· A2PG provides top of the industry benefits including 401(k) with company contributions, fully funded health insurance without employee deductibles, fully funded health savings account, and 20 days of paid time off.Compensation:· Commensurate with credentials. $50,000.00 to $70,000.00· Eligible for bonus considerations.COVID-19 ConsiderationsA2PG provides a spacious workspace, which eliminates close contact with coworkers and does not receive visitors frequently. A2PG provides employees with personal protective gear.Work RemotelyNoJob Type: Full-timePay: $50,000.00 – $70,000.00 per yearBenefits:401(k)Health insuranceHealth savings accountPaid time offParental leaveRelocation assistanceSchedule:8 hour shiftEducation:Bachelor’s (Required)Work Location: One location

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