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    Regulatory Scientific Writer

    Aroga Biosciences
    0-5 years
    Not Disclosed
    San Diego
    10 May 22, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Description: Regulatory Scientific Writer

    About Us:

    Aroga Biosciences is a renowned clinical research organization specializing in providing top-tier regulatory writing services for biotech and pharmaceutical projects. With a team of highly experienced scientists, we excel in delivering submission-ready documents across a wide range of therapeutic areas. Our focus on regulatory medical writing is driven by a passion for contributing to the development of novel therapeutics, ultimately benefiting patients worldwide.

    Responsibilities:

    • Author, edit, and format regulatory documents, particularly nonclinical documents for IND submissions.
    • Ensure clarity, coherence, and accuracy of messaging in all documents.
    • Review technical content to identify gaps, risks, or challenges and provide constructive feedback.
    • Conduct literature searches and prepare literature reviews.
    • Present data effectively in text, tables, and figures.
    • Ensure document compliance with regulatory guidelines and industry standards.
    • Collaborate with project management personnel to develop document timelines and reviewer lists.
    • Lead document planning, including outlining, gathering relevant information, and managing timelines.
    • Initiate authoring and review cycles, routing documents for approval, and managing QC and publishing.
    • Maintain effective communication with clients and internal teams throughout the document lifecycle.
    • Lead project kickoff and comment resolution meetings.
    • Commit to personal professional development through training and independent research.

    Requirements:

    • Bachelor’s degree in a medically relevant field or life science; MS or PhD preferred.
    • Experience authoring scientific documents with clear presentation of scientific data.
    • Ability to critically review scientific content for clarity and accuracy.
    • Strong communication, project management, and time management skills.
    • Flexibility to adjust to shifting timelines and demands.

    Preferred Experience:

    • Familiarity with different document templates and style guides.
    • Experience with online collaborative authoring platforms.
    • Knowledge of drug development process and regulations.
    • Familiarity with IND contents, particularly nonclinical documents.

    Benefits:

    • Competitive salary.
    • Comprehensive medical, dental, and vision insurance.
    • Flexible work week and hybrid work schedule.
    • 401K options.

    For more information, visit www.arogabio.com.

    Join us at Aroga Biosciences, where we are dedicated to excellence in regulatory medical writing and making a difference in healthcare.

     

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