Group Lead Medical Monitoring
4 weeks ago
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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