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    Medical Writer Ii

    Parexel
    2+ years
    Not Disclosed
    Remote, USA
    10 Dec. 5, 2024
    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

    Medical Writer II (Home-Based, East Coast Region, US)
    Location: Home-Based from the continental US (East Coast Region)
    Company: Parexel

    About Parexel
    Parexel is one of the largest providers of medical writing services globally, having managed thousands of writing projects across 29 countries in North and South America, Europe, Asia, and Africa. As a result of continued success and customer satisfaction, Parexel's Medical Writing Team is expanding.

    Role Overview
    As a Medical Writer II at Parexel, you will be exposed to diverse project teams, therapies, and devices across various therapeutic areas. This role requires the ability to understand and meet client needs while maintaining high-quality results. You’ll work independently and collaboratively within clinical teams to produce essential clinical documentation for regulatory submissions and clinical trials.

    Key Responsibilities

    • Document Creation & Editing: Research, write, edit, and coordinate the production of clinical documents for regulatory submissions (e.g., study protocols, informed consents, clinical study reports, safety updates).
    • Client Interaction: May serve as the primary client contact and help manage client expectations, ensuring alignment of resources and timelines.
    • Collaboration: Work within cross-functional teams and maintain a flexible approach to new tasks. Understand the roles of other team members, providing leadership where necessary.
    • Project Management: Efficiently manage multiple tasks, prioritize effectively, and meet deadlines while maintaining attention to detail.
    • Quality & Compliance: Produce documents of high quality, demonstrating attention to detail, proactivity, and adherence to industry guidelines and regulations (e.g., ICH-GCP).

    Required Skills

    • Communication: Strong interpersonal, verbal, and written communication skills.
    • Project Management: Ability to plan and identify critical paths, managing tasks proactively.
    • Adaptability: Flexibility in handling diverse work assignments and learning new concepts.
    • Team Collaboration: Experience working in matrix environments with an understanding of teamwork dynamics.
    • Client Engagement: Ability to build trust and establish lasting relationships with clients, contributing to business growth.

    Knowledge & Experience

    • Clinical Research Understanding: Knowledge of the drug development process and clinical research regulations.
    • Scientific Writing: Extensive experience in writing clinical documents, especially study protocols, informed consents, clinical study reports, and safety update reports.
    • Technical Skills: Advanced proficiency in MS Word, and familiarity with document management systems, SharePoint, and Excel.
    • Language Skills: Fluent in written and spoken English with a keen eye for grammar, punctuation, and phraseology.

    Education

    • Bachelor’s degree in Life Sciences/Health Related Sciences or equivalent.

    Why Parexel?
    At Parexel, you’ll work in a collaborative and dynamic environment with opportunities for growth, learning, and making an impact in the world of clinical research.

    Equal Opportunity Employer
    Parexel is committed to equal employment opportunities, offering consideration for employment without regard to legally protected status (e.g., race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status).

    #LI-REMOTE

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