27/10 Nizam
Manager at Arise

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Medical Writing Role (2-14 yrs)

Bangalore/Cuttack/Karnataka/Odisha/Assam/Puri Job Code: 23433

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.

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