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Sr Medical Writer (Redaction)

5 - 10 years

8 - 16 Lacs

Pune

Posted:1 week ago| Platform: Naukri logo

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Skills Required

anonymization Clinical Trial Transparency medical writer Medical Writing Redaction CTT

Work Mode

Remote

Job Type

Full Time

Job Description

Role & responsibilities: 1. Authoring and Quality Assurance of Project Activities Executes project specific activities with high quality and in defined timelines according to standard processes and operating procedures Marking /QC/Review and/or editing of pertinent documents such as: Clinical study documents or any other documents for regulatory submission i.e., clinical study reports, patient narratives, clinical summaries etc. for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH) Protocol and results summaries to support clinical trial disclosure commitments Systematically perform quality control checks of documents prepared by colleagues against pre-specified checklist generated in the project or SOP Perform detailed analyses on a planned and ad hoc basis, relating to processes and their outputs Ensure to abide with Client process Preferred candidate profile: Experience in redactions/anonymization of clinical documents as part of preparation for different regulations. Well versed with Health Canada /EMA policy.

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