Lead Medical Operations

Lead Medical Ops for medical oversight of global clinical studies

Lead – Medical Operations

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

Apply Link- Apply Link mentioned in below

Dr. Reddy's Laboratories is an Indian multinational pharmaceutical company based in Hyderabad. The company was founded by Kallam Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited.[2] Dr. Reddy's manufactures and markets a wide range of pharmaceuticals in India and overseas. The company has over 190 medications, 60 active pharmaceutical ingredients (APIs) for drug manufacture, diagnostic kits, critical care, and biotechnology.
Dr. Reddy's began as a supplier to Indian drug manufacturers, but it soon started exporting to other less-regulated markets that had the advantage of not having to spend time and money on a manufacturing plant that would gain approval from a drug licensing body such as the U.S. Food and Drug Administration (FDA). By the early 1990s, the expanded scale and profitability from these unregulated markets enabled the company to begin focusing on getting approval from drug regulators for their formulations and bulk drug manufacturing plants in more-developed economies. This allowed their movement into regulated markets such as the US and Europe. In 2014, Dr. Reddy Laboratories was listed among 1200 of India's most trusted brands according to the Brand Trust Report 2014, a study conducted by Trust Research Advisory, a brand analytics company.[3]
By 2007, Dr. Reddy's had seven FDA plants producing active pharmaceutical ingredients in India and seven FDA-inspected and ISO 9001 (quality) and ISO 14001 (environmental management) certified plants making patient-ready medications five of them in India and two in the UK.[4]