Group Lead Medical Monitoring - Hyderabad, India - Dr Reddy's Laboratories Limited

Description

The position will be responsible for ensuring complete medical inputs to, and oversight of all clinical studies being conducted for all Dr.Reddys Biologics products under development.

Location: Biologics, Dr Reddy's Laboratories Limited, Bachupally, Hyderabad

Education & Experience

MBBS/MD with experience in clinical research field in Bio pharmaceutical industry, preferably in Therapeutic Proteins/Biosimilars with yrs of experience.

Responsibilities

Medical Monitoring and Drug Safety

• Safety management and medical monitoring of clinical trials
• Preparation/review of safety monitoring and medical monitoring plan
• Impart therapeutic area and Protocol training to internal and external teams as required
• Address and manage all medical queries related to the molecule in development, and the protocol related queries – both from internal and external stakeholders, including but not limited to patient eligibility criteria, protocol compliance and AE /SAE medical management.
• Review and inputs to various clinical study documents including but not limited to, Investigators Brochure, Clinical study protocol, ICD, Clinical study report.
• Review of regulatory submission documents such as Executive summaries/ dossiers, and compilation of appropriate (clinical) sections, as required.
• Active lead/participation/presentations for DSMB Meetings, NDAC meetings, Therapeutic Area Expert meetings, Therapeutic Area Advisory meetings, Ad board Meetings, as per organizational requirements
• Co-ordination and partnering with external partners (CRO/ alliance) to ensure best safety interests of the clinical trial subjects.
• Work closely with internal stakeholders – both within and outside the functional domain, and with the external partners to ensure timely and quality deliverables, and streamlined functioning of the projects as needed.
• Any other responsibility, as delegated by Head Medical Sciences

Mandatory Skills

medical acumen, communication, GCP, medical operations/medical monitoring in global clinical studies

MBBS