Are you a skilled pharmaceutical professional seeking a dynamic opportunity? Look no further! TCS, a global leader, is actively recruiting talented individuals for the position of Regulatory Medical Writer. At TCS, we empower our clients to shape the future through a fusion of technology expertise and business intelligence. Our mission is simple yet powerful: to assist our customers in achieving their business objectives by delivering innovative, top-notch consulting, IT solutions, and services. We are dedicated to making the collaboration process enjoyable for all stakeholders, ensuring seamless and transformative experiences.
Post: Regulatory Medical Writer
Job Description
1. 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)
2. 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
3. Attention to detail, work under stringent timelines on need basis, and to switch between projects/documents, as applicable
4. Perform project management activities for the assigned project/document to ensure timely completion of the projects with quality
5. Identify project risks, if any, and implement corrective and preventive action
6. Impart process related trainings to the new medical writers in the team. Mentor new joiners or junior writers, as applicable
7. Identifying and implementing continuous improvement activities in the process, as applicable
8. Complete assigned (TCS/client) trainings within stipulated timelines
9. 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
Location: Mumbai
End Date: 30th November, 2023
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