Group Lead Medical Monitoring

4 weeks ago


Hyderabad, India Dr Reddy's Laboratories Limited Full time
Job 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 8  - 13 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


Qualifications

MBBS




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