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Research Associate

2-4 years
Not Disclosed
10 Nov. 26, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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

Research Associate – Report Writer

Location: Ahmedabad, India
Job Type: Full-Time
Experience Required: 2 to 4 years

Position Overview

The Research Associate – Report Writer will support bioanalytical, clinical, and preclinical research programs by preparing accurate, compliant, and well-structured scientific reports. This role requires strong scientific writing expertise, meticulous attention to detail, and a solid understanding of regulatory expectations, including GLP, GCP, FDA, EMA, OECD, and ICH guidelines. The position involves close collaboration with scientific, quality, and project management teams to ensure high-quality study documentation that meets both sponsor and regulatory requirements.


Key Responsibilities

  • Prepare draft and final study reports for bioanalytical, clinical, and preclinical studies in accordance with SOPs, GLP standards, and global regulatory guidelines.

  • Review raw data, analytical results, and statistical outputs to ensure accuracy, completeness, and consistency prior to report creation.

  • Collaborate with Scientists, Quality Assurance, and Project Managers to collect study-specific information and accurately represent all technical details.

  • Maintain organized documentation, version control, and complete traceability for report drafts and related communications.

  • Ensure all reports align with sponsor expectations and meet internal CRO quality benchmarks.

  • Support the preparation of summary documents, method validation reports, and content for regulatory submissions such as eCTD.

  • Provide timely responses to sponsor queries and assist in regulatory audits focused on study documentation.

  • Uphold the highest standards of confidentiality, data integrity, and regulatory compliance during all stages of report development.

  • Apply strong scientific writing and editing skills to generate clear, concise, and scientifically sound reports.

  • Demonstrate working knowledge of GLP, GCP, and global regulatory requirements applicable to research documentation.

  • Use Microsoft Word, Excel, and PowerPoint effectively for report preparation and supporting documentation.


Required Qualifications and Experience

  • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or a related scientific discipline.

  • 2 to 4 years of experience in scientific writing, report preparation, or a similar role within a CRO, pharmaceutical, or research environment.

  • Strong understanding of GLP, GCP, and regulatory documentation standards.

  • Proven ability to interpret scientific data and prepare structured, compliant reports.

  • Excellent written communication and documentation skills.

  • Proficiency in Microsoft Office Suite.