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