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    Medical Writing Quality Reviewer

    Pfizer
    3-5 years
    Not Disclosed
    Bengaluru Chennai Delhi Mumbai New Delhi Remote
    10 Aug. 16, 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, 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

    What You Will Achieve

    In this role, you will oversee and conduct quality reviews to ensure the delivery of accurate, compliant, and submission-ready documents prepared by Medical Writing and other clinical teams. Your responsibilities will encompass a range of documents, including protocols, clinical study reports, disclosure documents, clinical summaries/overviews for marketing applications, briefing documents, regulatory responses, and related correspondence and presentation materials.

    How You Will Achieve It

    Quality Reviews:

    • Conduct quality reviews with minimal supervision and participate in quality projects within agreed timelines.
    • Verify the accuracy of document content using source materials, including clinical regulatory documents (e.g., protocols, clinical study reports, CIOMS reports) and data tables, figures, and listings.
    • Ensure internal consistency within documents and across related documents.
    • Confirm that documents adhere to internal and external standards, such as document templates, company style guides, and publishing requirements.
    • Record findings, identify necessary corrections, and collaborate with document authors and team members to resolve issues.
    • Address issues impacting document timelines and propose recommendations for process improvements to reduce recurring errors.

    Special Assignments/Projects:

    • Engage in quality processes and process improvement initiatives.
    • Contribute to the training of colleagues on quality standards and processes.

    Qualifications:

    • A minimum of a Bachelor’s degree in a life science discipline is required; an advanced degree is preferred.
    • Experience:
      • BS/BA with at least 5 years of experience in document QC and/or medical writing in the pharmaceutical or biotech industry.
      • MS/MA with at least 3 years of relevant experience.
    • Ability to work independently with minimal supervision and adapt to changing conditions under pressure.
    • General understanding of medical terminology, clinical trials, and the drug development process.
    • Strong organizational skills with the ability to prioritize multiple projects and meet deadlines.
    • High fluency in written and spoken English.
    • Excellent interpersonal and communication skills, with the ability to establish and maintain professional and productive relationships.

    Work Location Assignment: Flexible

    Pfizer is an Equal Opportunity Employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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