Medical Writing Role (2-14 yrs)
Designation : Medical Writing
Job description :
- Preparation of documents and facilitation of documentation management in R&D while following established guidelines for correctness, completeness and clarity.
- Preparation of documents such as Manufacturing Batch Records, Study Protocol and Reports, Stability Protocols, Product Development Report, response to regulatory queries, based on the scientific input from the Formulation team.
- Preparation of documents such as, Test Procedures, Specifications, Method Evaluation Reports, Validation Protocols and Reports, Risk Assessment Documents, etc. based on the scientific input from the Analytical team.
- Preparation of high impact presentations including graphs, charts and statistical analysis of data.
- Submission of documents for signatures and coordinating their flow, archival and retrieval to ensure timely flow and publish monthly performance metrics.
- Continuously improve documentation systems to increase efficiency and compliance with cGMP and/or other regulatory requirements.
- Perform other duties as assigned or delegated.
- Comply with FDA guidelines/Company Policies of Data Integrity.
- Perform necessary transactions in SAP and other project / manufacturing systems, create material master, recipe, bill of materials and other changes as per change control.
