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    Medical Writer

    Advity Research
    3-5 years
    upto 9 LPA
    Hyderabad
    7 Aug. 7, 2024
    Job Description
    Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D 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

    Job Title: Medical Writer

    Location: Hyderabad

    Experience Required: 3 to 5 years

    Employment Type: Full Time

    Department: BA/BE & Clinical Trials

    Qualification:

    • Graduate/Post Graduate/Doctorate degree in Life Sciences, Pharmacy, Medical Sciences, or equivalent degree.
    • Fluency in English.

    Mode of Work: On premise

    Job Description:

    • Management and Coordination: Overall management and coordination of MW (Medical Writing) activities performed by the MW department.
    • Cross-Functional Interaction: Interact cross-functionally with other departments (e.g., Clinical Operations, Medical Affairs, QA, PM) to ensure the timely completion of high-quality deliverables.
    • Compliance: Ensure that all work done by the MW department is conducted in compliance with Advity’s Research Policies, SOPs, and relevant guidelines.
    • Writing and Reviewing: Write and review protocols, ICFs, and clinical study reports for Phase I-IV studies (e.g., PK, FIM, BE/BA, safety), as needed.
    • Project Timelines: Set up and monitor assigned project timelines by maintaining department scheduling tools.
    • Representation: Represent Advity in discussions with sponsors, at conferences, and client meetings.
    • SOP Development: Work with the Quality Assurance group in the development, revision, and implementation of Standard Operating Procedures as required.
    • Guideline Knowledge: Acquire and maintain knowledge of national and international guidelines.
    • Training Participation: Participate in training sessions.
    • Safety: Work in a safe manner that does not endanger yourself or co-workers.
    • Additional Duties: Execute other duties as may be required by the management of Advity as training and experience allow.

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