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Medical Writer (Clinical Research)

2-8 years
Not Disclosed
10 April 30, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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

 

Job Title:

Medical Writer (Clinical Research)


Company:

Sun Pharma Laboratories Ltd


Location:

Sun House – Corporate Office, Goregaon East, Mumbai


Posting Date:

April 11, 2025


Job Summary:

The Medical Writer will be responsible for preparing clinical documentation including protocols, investigator brochures, clinical study reports, manuscripts, abstracts, posters, and regulatory documents. The role involves collaboration across functions and with external vendors to ensure scientific accuracy, regulatory compliance, and timely delivery.


Key Responsibilities:

Systems and Compliance:

  • Ensure adherence to clinical and regulatory guidelines, SOPs, and ICH-GCP standards.

  • Collaborate in the development and review of study protocols and related clinical documents.

  • Maintain compliance with SOPs specific to clinical medical writing.

  • Support quality review processes and contribute to performance improvement metrics.

  • Understand randomization and blinding techniques, and coding systems (e.g., MedDRA, WHO-DD).

Medical Writing Activities:

  • Prepare high-quality protocols, CSRs, appendices, and SOPs.

  • Perform literature reviews to support document development.

  • Draft and review journal manuscripts, abstracts, and articles for publication.

  • Support regulatory meetings by preparing necessary documents for SEC submissions.

  • Coordinate with vendors for manuscript development and procurement of clinical scales (e.g., PROs).

  • Collaborate with data management and biostatistics teams for data review, SAP development, and analysis.

  • Register studies in clinical trial registries like CTRI.

  • Mentor junior medical writers as needed.


Required Skills and Qualifications:

  • Education: B. Pharma, M.Sc, M.Pharma, PhD, BAMS, BHMS, or Life Sciences.

  • Experience: 2–8 years of medical writing experience in clinical research.

  • Proficiency in ICH, GCP/GDP, IMRaD, CONSORT, and regulatory guidelines (FDA, ICMR, DCGI).

  • Familiarity with clinical trial documentation standards and publishing processes.

  • Strong analytical, writing, and communication skills.

  • Ability to work independently and in matrix environments.