Medical Writer

3-6 years years

Preffered by Company

Mumbai

Not Disclosed May 28, 2024

Job Description

Job Type: Full Time Education: B.Pharm/M.Pharm/PharmD Skills: Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Medical Writer

Location: Mumbai

Experience Required: 3 - 6 years

Application Deadline: 22-Jun-2024

Job ID: 309136

Job Function: BUSINESS PROCESS SERVICES

Role Category: Executive

Job Description: 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)

Application Details: Interested candidates can apply by the specified deadline. Please ensure to share your resume and relevant qualifications.

Additional Information: This position offers the opportunity to work in a dynamic environment and contribute to important regulatory submissions that impact patient care and therapeutic development.

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