Gurugram

To conduct audits and assessments of manufacturers of In Vitro Diagnostic Medical Devices (IVDs) against applicable regulatory requirements, quality management system standards, and conformity assessment procedures.

Maintain safety tracking systems and ensure timely completion of assigned activities and deliverables. Conduct MedDRA coding, drug coding, and maintenance of drug dictionaries as required.

Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development

Writes and issues audit reports, ensuring clear communication of audit findings to the auditees and relevant management. Reviews responses to audit findings for appropriateness and completeness.

Risk Evidence Writer inputs into of all aspects of the Reckitt global signal management process, including signal surveillance for medicines, medical devices, cosmetics and other Reckitt products.

Support pharmaceutical documentation and compliance activities. Assist in quality processes and record management. 

Performs E2E process related scientific writing that includes but not limited to manage workflow in PubConnect, create publication plan, author approvals, pre-submission queries, submission activities etc.

Ph.D/MD/MS/MDS or equivalent degree in science. Demonstrable experience in Neuroscience or RNA Biochemistry in the form of publication. NBRC

Lead ISI Mark and CRS certification projects from application to grant. Prepare and review all documentation for BIS portal submissions. Coordinate product testing with BIS-recognized laboratories