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Analytical Writer

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ICON
2-4 years
Not Disclosed
Bangalore, India
10 Feb. 12, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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

Analytical Writer – Bioanalytical & Clinical Research

Location: Bangalore, India
Work Model: Office with Flex
Employment Type: Full-Time
Job ID: JR141947
Company: ICON plc

ThePharmaDaily.com is featuring an opportunity for an Analytical Writer with ICON plc, a global leader in healthcare intelligence and clinical research. This role is ideal for professionals from a CRO or pharmaceutical background who possess strong scientific writing capabilities and hands-on exposure to bioanalytical and clinical research environments.

Experience Required

2 to 4 years of relevant experience in bioanalytical laboratory processes and clinical or non-clinical study settings.


Role Overview

The Analytical Writer will be responsible for developing high-quality, regulatory-compliant bioanalytical and method validation reports that support global clinical development programs. This position plays a critical role in transforming complex laboratory data and scientific findings into structured, submission-ready documentation aligned with international regulatory standards.

The role requires collaboration with cross-functional teams including Project Managers, Bioanalytical Leads, and laboratory scientists to ensure accurate interpretation and presentation of study data. The Analytical Writer directly contributes to regulatory submissions, client deliverables, and overall study success.


Key Responsibilities

  • Prepare bioanalytical study reports and method validation documentation by compiling and synthesizing laboratory and project data

  • Translate scientific findings into clear, concise, and structured narratives suitable for regulatory and client review

  • Collaborate with Project Managers, laboratory teams, and study leads to clarify data interpretation and reporting requirements

  • Ensure documentation accuracy, consistency, and compliance with international regulatory guidelines

  • Format and finalize reports in accordance with eCTD (electronic Common Technical Document) submission standards

  • Review and incorporate internal and external feedback to maintain high documentation quality

  • Develop and maintain standardized reporting templates

  • Support study-related documentation and reporting deliverables as required


Required Qualifications

  • Bachelor’s degree in a scientific, biomedical, or life sciences discipline

  • 2 to 4 years of experience in a CRO, pharmaceutical, or bioanalytical laboratory environment

  • Working knowledge of bioanalytical techniques such as LC-MS/MS, HPLC, ELISA, ADA, NAb assays, and flow cytometry

  • Strong analytical skills with the ability to interpret complex scientific datasets

  • Excellent written and verbal communication skills in English

  • Proficiency in Microsoft Word, Excel, and Adobe tools for document preparation and formatting

  • High attention to detail, structured documentation approach, and strong organizational skills


Core Competencies

  • Bioanalytical report writing

  • Method validation documentation

  • Regulatory and submission-ready writing

  • eCTD compliance standards

  • Scientific data interpretation

  • Cross-functional collaboration

  • Quality-focused documentation management


Compensation and Benefits

ICON offers a competitive salary package aligned with industry benchmarks. The organization provides country-specific benefits designed to promote employee well-being, financial security, and work-life balance. Benefits may include:

  • Annual leave entitlements

  • Comprehensive health insurance coverage

  • Retirement planning programs

  • Life assurance coverage

  • Global Employee Assistance Programme (TELUS Health)

  • Flexible optional benefits such as wellness initiatives, childcare support, gym memberships, and travel subsidies


Equal Opportunity Commitment

ICON is committed to fostering an inclusive and accessible workplace environment. All qualified applicants will receive equal consideration without regard to race, religion, gender, disability, veteran status, or other protected characteristics. Reasonable accommodations are available during the recruitment and employment process.