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.
Gujarat :
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Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Osaka | Tokyo |Shanghai Sai :
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Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
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Greece |North Island :
Auckland |New Zealand :
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Vienna |Catalonia :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Remote Korea |Republic of Korea :
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McFarland | Green Way | Springville | Nairobi | Remote - South America (Latin Americal) | French | Melbourne | Remote, USA | Zaragoza | Medan | Lenexa | Switzerland | Remote - Africa | Bountiful | Remote | Castlebar | Leinster | Bishop | Lousiana | Thailand | Regulatory Labeling Manager (NA and LATAM Only) | Hungary | Texas | Riga | Faridabad | Remote - Europe | Belgium | Tulsa | Minnesota | Ireland | Remote - Middle East | Hammond | Manipal | Slovakia | Victoria | Blue Bell | Xzagreb |Republic of Colombia :
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Buenos Aires |Republic of Egypt :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
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