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Manager – Report Writing

0-1 years
12-16 LPA
5 Dec. 2, 2025
Job Description
Job Type: Full Time Education: MBBS, MD Pharmacology Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Manager – Report Writing

Lambda Therapeutic Research Ltd. | Ahmedabad, India

Req ID: 1403
Posted On: 6 November 2025
Experience Required: Fresher (0–1 year)
Salary (CTC): INR 12,00,000 – 16,00,000 per annum
Work Location: Ahmedabad, India
Category: Medical Writing / Clinical Research


About Lambda Therapeutic Research

Lambda Therapeutic Research Ltd. is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. With operational facilities in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland), Lambda provides end-to-end clinical research solutions to innovator, generic, and biotechnology companies worldwide.
The organization specializes in Phase II–IV clinical development, regulatory submissions, medical writing, biostatistics, and global clinical program management.


Position Overview

Lambda is seeking a Manager – Report Writing to support the development, review, and delivery of high-quality clinical documents for late-phase clinical studies. This role is open to freshers with 0–1 year of experience, making it an excellent opportunity for candidates with strong academic training in medical writing and clinical pharmacology.


Key Responsibilities

  • Author and review Clinical Study Reports (CSRs) for Phase II, Phase III, and Phase IV clinical studies.

  • Review eCRFs and Statistical Analysis Plans (SAPs) from a medical writing perspective.

  • Review Medical Coding outputs, data listings, and summary tables to ensure accuracy and consistency.

  • Draft Clinical Modules and other regulatory submission documents in alignment with global guidelines.

  • Prepare responses to regulatory queries during submission and review processes.

  • Deliver medical writing–related training sessions to internal project teams.


Key Deliverables

  • High-quality Clinical Study Reports for late-phase clinical trials.

  • Regulatory-compliant Clinical Modules for submission packages.

  • Structured and accurate responses to regulatory authority queries.


Required Experience

  • 0–1 year of experience in CSR writing or medical writing for late-phase clinical research projects.

  • Exposure to medical writing fundamentals, literature search methods, and structured clinical documentation is preferred.


Educational Qualification

  • MD Pharmacology (mandatory)