Medical Writer
Tata Consultancy Services•Mumbai, Maharashtra, India
fulltime
Health Care Provider
5+ years
TCS is hiring for Regulatory Medical Writer!!!
Job Location – Mumbai/Pune/Banaglore
Experience Range – 5 to 13 Years
Educational Qualification(s) Required – Any Life Science Graduate
Roles & Responsibilities
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.