inVentiv International Pharma Services Pvt. Ltd. Looking for SR MEDICAL WRITER (ICF WRITING) at Pune, Gurgaon, Hyderabad Full Time

Job Description

JOB SUMMARY

Serves as a senior medical writer on clinical study or regulatory project teams. Writes, edits, and coordinates content for clinical/regulatory while serving as primary technical contact with the internal team and the client.

Key Skills: ICF document Writing /Assent forms/Clinical Trail experience/Project management

Location: Hyderabad/Gurgaon/Pune/Homebased

JOB RESPONSIBILITIES

• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Acts as lead for assigned writing projects.
• Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
• Develops or supports a variety of documents that include, but not limited to:
• Clinical study protocols and clinical protocol amendments;
• Clinical study reports;
• Patient narratives;
• Clinical development plans;
• IND submissions and annual reports;
• Integrated summary reports;
• NDA and (e)CTD submissions;
• Investigator brochures, as well as;
• Clinical journal manuscripts, clinical journal abstracts, and client presentations.
• Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
• Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
• Serves as peer reviewer on internal review team providing review comments on draft and final documents.
• Adheres 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.
• Performs on-line clinical literature searches, as applicable.
• Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
• Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
• Completes required administrated tasks within the specified timeframes.
• Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).