Anand Krishnan

Senior Medical Writer - Janssen Lead (Usa) for Regmw @Syneos Health

Los Angeles, CA, US

Mentor and lead less experienced medical writers on complex projects, as necessary.Prepare medical writer training modules to help new and seasoned medical writers. Act as lead for assigned writing projects.Manage medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.Develop or support Clinical study protocols and clinical protocol amendments;Identify and propose solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.Review statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.Interact with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.Serve as peer reviewer on internal review team providing review comments on draft and final documents.Adhere to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.Perform on-line clinical literature searches, as applicable.Maintain familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.Maintain awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.

Center for Biotechnology, Anna University

Ph.D., Biotechnology