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    Regulatory Medical Writer

    Proclinical Staffing
    3-5 years
    Not Disclosed
    Remote, USA
    10 July 23, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

    About the Job: Regulatory Medical Writer - Permanent - Remote

    Proclinical is seeking a Regulatory Medical Writer for a regulatory consulting firm located in Virginia. This position is remote-based within the United States.

    Primary Responsibilities:

    In this role, you will:

    • Write and review regulatory submissions, such as Pre-INDs, INDs, CTDs, ODDs (FDA and EMA), and white papers.

    Skills & Requirements:

    • Education: PhD in a life science or related field of study.
    • Experience: Minimum of 3-5 years relevant experience in Regulatory Affairs within the pharmaceutical or biotechnology industry. Recent experience working at a CRO or pharmaceutical/regulatory consulting firm is preferable.

    The Regulatory Medical Writer Will:

    • Demonstrate expertise in FDA-regulated product development.
    • Have knowledge of ex-US drug and device development (a plus).
    • Experience in writing and reviewing regulatory submissions, including Pre-INDs, INDs, CTDs, ODDs (FDA and EMA), and white papers. Experience with CMC writing (FDA and EMA) is preferred.
    • Understand the client’s problems, conceptualize solutions, and achieve task objectives.
    • Contribute scientific and innovative thinking.
    • Produce high-quality work acceptable to the senior consultant, on time and within budget.
    • Effectively manage deadlines and multi-task.
    • Actively engage in publishing articles.
    • Perform literature reviews.

    If you have any questions or need assistance with the application, please contact Phu Huynh at (+1) 646-779-7961 or p.huynh@proclinical.com.

    Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. Proclinical Staffing is an equal opportunity employer.

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