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    Medical Writer I

    Parexel
    0-2 years
    Not Disclosed
    Remote
    10 Jan. 3, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Here’s a polished summary for your review:

    Position: Medical Writer
    Type: Remote

    Job Purpose:
    The Medical Writer plays a vital role in preparing high-quality regulatory, pharmacovigilance, and clinical trial documentation. Responsibilities include managing scheduled and unscheduled aggregate safety reports, clinical study report narratives, and signal detection processes. The writer ensures compliance with international conventions, client-specific requirements, and internal SOPs while maintaining data accuracy and integrity.

    Key Responsibilities

    Aggregate Reports Management

    • Develop and update a wide range of safety documents, including PSURs, PBRERs, DSURs, RMPs, and more.
    • Conduct critical appraisals and systematic reviews for inclusion in safety reports.
    • Generate line listings, identify discrepancies, and ensure compliance with timelines.
    • Review and confirm consistency and accuracy across reports.

    Clinical Study Report Narratives

    • Prepare accurate and cohesive narratives based on safety and clinical database outputs.
    • Perform quality checks and ensure alignment with client and regulatory guidelines.

    Signal Detection & Management

    • Conduct qualitative and quantitative signal detection analyses.
    • Manage the end-to-end signal management process, including tracking, assessment, and presentation.

    General Tasks

    • Maintain comprehensive knowledge of drug safety profiles, regulatory obligations, and clinical studies.
    • Participate in audits, inspections, and client-specific training sessions.
    • Serve as the primary client liaison to ensure quality deliverables and satisfaction.
    • Mentor new team members and assist with workload delegation.

    Skills and Qualifications

    Core Skills

    • Analytical and problem-solving abilities.
    • Strong written and verbal communication.
    • Excellent organizational, multitasking, and time management skills.
    • Attention to detail with an ability to synthesize complex medical data.

    Technical Competencies

    • Proficiency in Microsoft Office (Word, Excel, PowerPoint) and web-based tools.
    • Familiarity with regulatory and medical terminology.
    • Expertise in literature review and database searches (e.g., PubMed).

    Educational Background

    • A degree in life sciences, health sciences, or biomedical sciences (e.g., Pharmacy, Biotechnology).
    • Advanced degrees in Medicine, Dentistry, or Nursing with clinical exposure preferred.

    Experience

    • Prior experience in regulatory writing or pharmacovigilance is desirable.

    Why Join Us?
    At Parexel, we prioritize professional growth through mentorship, training, and collaborative teamwork. As part of a global, inclusive organization, you’ll have opportunities to make a meaningful impact in advancing healthcare.

    Apply Now: Click here to apply or explore more opportunities at Parexel.

    This format is clear, concise, and tailored for candidates seeking comprehensive details about the position. Would you like to add or modify anything further?

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