Job Description

Vacancy for Regulatory Medical Writer at Tata Consultancy Services 2023.

Job Title/Position:

Regulatory Medical Writer

Job vacancy for Pharmacy, Life sciences

Mumbai

As per process requirement and assigned primary responsibility support narratives (draft and QC); DSURs/CSRs (draft and peer review) and perform independent QC of regulatory/safety /publication documents (including but not limited to CSR, IB, Protocol, RMP, DSUR, HLD, Manuscript, abstract, poster)
Ensure that the narratives, DSUR, CSR, QC’ed documents are in accordance with the client SOPs, guidelines and agreed timelines and comply with performance metrics as per client quality standards
Attention to detail, work under stringent timelines on need basis, and to switch between projects/documents, as applicable
Perform project management activities for the assigned project/document to ensure timely completion of the projects with quality
Identify project risks, if any, and implement corrective and preventive action
Impart process related trainings to the new medical writers in the team. Mentor new joiners or junior writers, as applicable
Identifying and implementing continuous improvement activities in the process, as applicable
Complete assigned (TCS/client) trainings within stipulated timelines
Provide timely data (study tracker, quality metrics, billing numbers/effort hours) for preparing relevant (e.g. quality, TAT, effort hours, etc.) and project status updates, as defined by the TCS/client requirements

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