About This Role
Writing and reviewing clinical documentation for regulatory submissions is the core of this medical writer role, ensuring compliance with internal and external guidelines. The position involves supporting various clinical studies and contributing to process improvement initiatives.
Responsibilities
- Prepare and review protocols, informed consent documents (ICD), synopses, and other study-specific documents like patient diary cards
- Prepare and review investigator brochures
- Evaluate trial feasibility (preliminary and detailed) for patient-based clinical studies with the medical team for various regulatory submissions
- Support reference literature searches as required for assigned projects
- Provide protocol training to monitors and site teams if required
- Prepare and review clinical study reports (CSRs) for phase trials conducted by the Clinical Operations Department of Veeda as per regulatory requirements and defined timelines in the project grid - Study execution sheet, in coordination with the Project Manager
- Prepare and review full CSRs, abbreviated CSRs, synoptic CSRs, shells, and interim reports as per sponsor necessity
- Review statistical analysis plans, mock shells, and table/figure/listing specifications for appropriate content
- Perform literature searches/reviews as necessary to obtain background information and develop documents
- Ensure compliance with sponsor audits and regulatory inspections (e.g., USFDA, EMA, DCGI etc.) and reply to queries/deficiencies
- Ensure and improve the quality and presentation of reports through writing, editing, and/or managing the production of high-quality clinical documentation (e.g., Study Report, Summary Documents) and ensure compliance of documentation to internal company standards and external regulatory guidelines
- Prepare and review departmental SOPs and other departmental SOPs as required
- Ensure that reports, appendices, and related material are archived / e-archived in a timely manner
- Prepare project summaries and submit to reporting head/designee (if required)
- Develop and maintain the necessary templates, formats, and styles to ensure that generated documents meet industry, internal, client, and regulatory requirements
- Participate in departmental or interdepartmental process improvement and training initiatives
- Perform any other duties as assigned by the Department Head
