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Medical Writer : Mumbai : Pune : Apply Now

4 - 9 years

10 - 15 Lacs

Pune Mumbai (All Areas)

Posted:3 months ago| Platform: Naukri logo

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Skills Required

Medical Writer Pharmacovigilance IQVIA Regulatory Writing ICON Cognizant MBBS PV Medical Scribe Medical Summarization Merck Clinical Document Preparation Novartis Clinical Research Parexel Drug Safety Patient Safety EXL Medical Affairs PrimEra Clinical study Life Science

Work Mode

Work from Office

Job Type

Full Time

Job Description

Hi Hiring for the leading ITES Company for Regulatory Medical Writer Profile. Job Description: Experience : 4 - 11 years of experience in Medical Writing domain. Location: Mumbai, Pune, Bangalore Salary: 8 LPA to 12 LPA To Connect WhatsApp 'Hi' @9151555419 and search for Job in Mumbai / Pune / Bangalore Roles and Responsibilities: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Medical Writing Mumbai (Job Code # 56) b) For Position in Pune Search : Medical Writing Pune (Job Code # 57)

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