Medical Writer

• The Medical Writer will be responsible for preparing and reviewing clinical documents for regulatory submissions across various therapeutic areas
• This includes but is not limited to Protocols, Clinical Study Pharmacology Reports, Clinical Study Reports, Narratives, Post Approval Documents, Clinical Summaries of Safety, and Efficacy, as well as Common Technical Document Modules
• The role involves quality checks of all clinical documents, initiating start-up meetings with study teams for document creation, and working in coordination with both internal and external team members

Responsibilities:

• Prepare and review clinical documents for regulatory submissions.
• Perform quality checks on clinical documents.
• Initiate and conduct start-up meetings related to the development of clinical documents.
• Collaborate with study teams to ensure effective document development.
• Manage project timelines for document development.
• Ensure all clinical documents adhere to Standard Operating Procedures, Document Standards, and Guidance documents.
• Review statistical analysis plans and associated tables, figures, and listings as required.

Desired Skills:

• Proficiency in Medical Writing and Protocol development.

Qualifications:

• Bachelor of Pharmacy (B.Pharm)
• Master of Pharmacy (M.Pharm)