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Medical Writer II

2.00 to 5.00 Years   Mohali   20 Feb, 2023
PAREXEL International
Job LocationMohali
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaTechnical Writing
EmploymentTypeFull-time

Job Description

    • End-to-end authoring of PBRER/PSUR
    • Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize PBRER/PSUR for submission to regulatory authorities.
    • Revise PBRER/PSUR drafts based on the review comments from team members to ensure inclusion of all relevant input.
    • Author Safety sections for the PBRER/PSUR and perform case level analysis of the retrieved cases
    • Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable.
    • Perform literature reviews to obtain background information pertaining to the safety topic analysis.
    Quality Control:
    • Ensure that all work is complete and of high quality prior to team distribution or shipment to client.
    • Confirm data consistency and integrity across the document.
    • Prepare documents for publishing readiness, when applicable.
    • Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable.
    • Provide suggested alternative content when contributors provide content that does not meet document needs.
    • Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review.
    ,

Keyskills :
clinical trialsresearchstandard operating procedurescopy editingdigital conversionmedical editing

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