Job Description

- 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 strong 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.