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.
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