Role: Aggregate Report Writer
Experience: 4 to 6 years
Location : Mumbai
Authoring/editing experience in safety documents like Development safety update report (DSUR), Periodic benefit risk evaluation report (PBRER), Risk Management Plans (RMPs),
JD:
- Authoring/editing of safety documents
- Ensure adherence to established timelines, regulatory guidelines and applicable standards, styles, guidelines and processes
- Peer review/quality review of the clinical/safety documents within established timelines with adherence to applicable guidelines and processes, using appropriate checklists
- Assist senior writers to facilitate effective interactions and information exchange/communication among co-authors and reviewers as appropriate
- 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 and industry standards
- Assist senior writers in training and mentoring activities as applicable
- Assist senior team members in internal and Client deliverables
Apply through below link:
(5) Aggregate Report Writer | Tata Consultancy Services | LinkedIn
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