Tcs Hiring Senior Medical Writer In Mumbai Job In Tata Group In India, Mumbai

TCS Hiring for Senior Medical Writer in Mumbai!Hiring for Roles: Senior Medical WriterWork location: MumbaiShift: Comfortable to work in 247 environmentJob description:Overall 5 years' of authoring/editing experience in medical writing domain across different therapeutic areas in safety documents like Development safety update report (DSUR), Periodic benefit risk evaluation report (PBRER/PSUR), Periodic Adverse Drug Experience Report (PADER/PAER) preferred Experience in preparation of safety documents necessary for national and international regulatory submissions to the US, European and other regulatory agencies Clear, concise and scientific style of writing, with attention to detail Strong analytical skills and expertise in writing and review of scientific/clinical/safety documents Good knowledge of clinical research domain, ICH GCP principles, Common Technical Document (CTD) structure and regulatory requirements Effective coordination and presentation skills - good organization and time management skills Exceptional interpersonal, verbal and written communication skills Computer Literate: Knowledge of MS Word, PowerPoint, Adobe Acrobat, MS Excel, etcResponsibilitiesSetting, discussing and meeting expectations of the document during kick off and subsequent meetings Authoring/editing of safety documents, as mentioned above Ensure adherence to established processes, timelines, regulatory guidelines and applicable standards, styles, and client specific guidelines Peer review/quality review of safety documents within established timelines with adherence to applicable processes and guidelines Keep abreast of project status, clinical operating plans and ongoing/new studies as well as scientific literature within assigned project.

Maintain and develop current knowledge of regulatory guidelines, technological advances andindustry standards Work in collaboration with the peer or senior medical writer on active projects, as applicable

Tata Group is looking for .

Tata Group is looking for Any Graduate / Post Graduate profile candidates.