Medical Writer Executive Vacancy for BPharm and MPharm graduates at TCS Mumbai

Medical Writer Executive Vacancy at TCS Mumbai

Job Description

Role: – Medical Writing

Location: – Mumbai

Job Profile
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.

Initiates 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

Job Function: BUSINESS PROCESS SERVICES

Role: Executive

Job Id: 309136

Desired Skills: Medical Writing | Protocol

Qualifications : BACHELOR OF PHARMACY, MASTER OF PHARMACY

Last date:22/6/2024

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