Research Associate The Research Associate - Report Writer will be responsible for preparing clear accurate and compliant study reports for bioanalytical clinical and preclinical studies The role requires strong scientific writing abilities attention to detail and the capability to work closely with cross-functional teams to ensure high-quality documentation aligned with SOPs GLP and global regulatory guidelines FDA EMA OECD ICH Roles Responsibilities Develop draft and final study reports for bioanalytical clinical or preclinical studies in accordance with SOPs GLP and applicable regulatory guidelines Review raw data analytical results and statistical outputs for accuracy completeness and consistency prior to report preparation Collaborate with Scientists QA and Project Managers to gather study details and ensure all relevant information is correctly represented in reports Maintain version control traceability and organized documentation for all report drafts and related correspondence Ensure reports meet sponsor expectations and adhere to internal CRO quality standards Support the preparation of summary documents method validation reports and content for regulatory submissions e g eCTD Assist in addressing sponsor queries and regulatory audit requests related to study documentation Maintain strict confidentiality data integrity and compliance throughout the reporting process Apply robust scientific writing and editing skills to develop clear precise and well-structured reports Demonstrate strong working knowledge of GLP GCP and regulatory requirements Utilize proficiency in Microsoft Office tools Word Excel PowerPoint for report preparation and supporting documentation

📌 Research Associate (Gujarat)
🏢 VITELY CORP
📍 Gujarat