Clinical Content Specialist

1 day ago

Mumbai, Maharashtra, India beBeeContent Full time ₹ 1,04,000 - ₹ 1,30,878
Job Title:

Clinical Content Specialist

Description:

The ideal candidate 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.

Responsibilities include 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.

  • Main 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.

Requirements:

We are seeking an experienced Clinical Content Specialist who has proficiency in Medical Writing and Protocol development. A Bachelor of Pharmacy (B.Pharm) or Master of Pharmacy (M.Pharm) degree is preferred.

About this role:

This position involves working closely with cross-functional teams to develop high-quality clinical documents that meet regulatory requirements. The successful candidate will have excellent communication skills and be able to work independently with minimal supervision.

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