Analytical Writer – Bioanalytical & Clinical Research
Location: Bangalore, Karnataka, India
Job Type: Full-Time | Office-Based
Industry: Clinical Research | Medical Writing | Bioanalytical Sciences
Reference ID: JR141947
Analytical Writer Job in Bangalore – CRO / Pharma Background Required
A leading global clinical research organization is seeking an experienced Analytical Writer to join its Medical Writing team in Bangalore. This role is ideal for professionals with a CRO or pharmaceutical background who specialize in bioanalytical reporting, method validation documentation, and regulatory-compliant scientific writing.
The selected candidate will support bioanalytical and clinical research projects by developing high-quality, accurate, and submission-ready documentation aligned with international regulatory standards. This position plays a critical role in transforming complex laboratory data into structured reports suitable for regulatory authorities, sponsors, and global stakeholders.
Key Responsibilities
Prepare and finalize bioanalytical study reports and method validation reports using data compiled from laboratory and project sources.
Interpret and translate complex scientific data into clear, concise, and regulatory-compliant narratives.
Collaborate closely with Project Managers, Bioanalytical Leads, and laboratory teams to ensure accuracy and completeness of documentation.
Review, edit, and refine documents for quality, consistency, and compliance with global regulatory standards.
Ensure alignment with eCTD (electronic Common Technical Document) submission requirements, including PDF formatting standards.
Maintain and enhance reporting templates to streamline documentation processes.
Support study-related documentation and deliverables in accordance with project timelines.
Required Experience
2 to 4 years of experience in a CRO, pharmaceutical, or bioanalytical laboratory environment.
Demonstrated experience in bioanalytical reporting and clinical or non-clinical study documentation.
Practical knowledge of laboratory methodologies including:
LC-MS/MS
HPLC
ELISA
ADA (Anti-Drug Antibody assays)
NAb (Neutralizing Antibody assays)
Flow Cytometry
Educational Qualifications
Bachelor’s degree in Life Sciences, Biomedical Sciences, Pharmacy, Biotechnology, or a related scientific discipline.
Advanced degrees are considered advantageous.
Required Skills & Competencies
Strong analytical thinking with the ability to interpret complex scientific data.
Excellent written and verbal communication skills in English.
Proficiency in Microsoft Word, Excel, and Adobe tools for structured document preparation.
Deep understanding of regulatory writing standards and submission formatting requirements.
Detail-oriented, organized, and capable of managing multiple projects simultaneously.
Collaborative mindset with strong stakeholder communication skills.
Why Apply for This Analytical Writer Role?
Opportunity to work with a globally recognized clinical research organization.
Exposure to international regulatory standards and global clinical trials.
Competitive compensation and comprehensive benefits package.
Health insurance coverage and retirement planning options.
Global Employee Assistance Program supporting professional and personal well-being.
Inclusive, diverse, and innovation-driven work environment.
Equal Opportunity Statement
The organization is committed to fostering an inclusive and accessible workplace. All qualified applicants will receive equal consideration without regard to race, gender, religion, disability, sexual orientation, national origin, or protected veteran status.
Reasonable accommodations are available for candidates requiring support during the application or interview process.
Apply Now
If you have a strong foundation in bioanalytical sciences and scientific writing, and you are seeking to advance your career in clinical research documentation and regulatory submissions, this opportunity in Bangalore could be your next strategic move.
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