Medical Writer

Position:

Department:

Location:

Key Responsibilities

• Literature search to prepare, review, and finalization of any clinical/non-clinical document.
• Preparation or review in support of feasibility and related proposal & synopsis.
• Preparation or review of Investigator Brochure, Investigational Medicinal Product/ Investigational Medical Device Dossier etc.
• Preparation and review of various clinical trial documents like clinical study protocol / clinical investigation plan, informed consent documents, patient diary cards, clinical study report/clinical investigational report and similar other documents etc.
• Preparation and review of common technical documents
• Preparation and review of briefing documents for various regulatory bodies.
• Preparation and review of Standard Operating Procedures (SOPs)
• To assist medical monitor in preparation and review of medical monitoring plan and safety management plan.
• To assist medical monitor in review of medical data
• To assist the medical monitor or compliance manager in handling of data safety monitoring board-related activities.
• To manage medical writing-related activities within the organization
• Authorized and responsible to monitor the quality objectives that have been established for the medical writing-related functions and reporting its compliance to the top management.
• Authorized and responsible to release relevant services to clients as per requirement.
• To address regulatory queries.
• To perform any other activities assigned by Head- MA or the management.

Qualifications & experience required

• Life Science Graduate/Post-Graduate.
• Minimum of 5 Years of Clinical Trial experience.