Designation : Medical WritingJob 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. (ref:biojoby.com)
www.biojoby.com
MNCJobsIndia.com will not be responsible for any payment made to a third-party. All Terms of Use are applicable.