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ASSISTANT GENERAL MANAGER/DEPUTY GENERAL MANAGER-MEDICAL AFFAIRS

ASSISTANT GENERAL MANAGER/DEPUTY GENERAL MANAGER-MEDICAL AFFAIRS

Hetero

5 - 9 years

0 Lacs

hyderabad telangana

Posted:6 days ago| Platform: Shine logo

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Skills Required

medical monitoring clinical trials cro protocol development risk management ctd mentoring training clinical documents review subject expert committee icsrs aggregate reports signal reports new product evaluation marketing requests

Work Mode

On-site

Job Type

Full Time

Job Description

As a Medical Monitor, your primary responsibilities will include: - Monitoring the in-house clinical trials and overseeing CRO medical monitoring of outsourced projects - Developing and reviewing clinical documents such as protocol, investigator's brochure, case record form, product rationale, prescribing information, drug interactions, etc. - Organizing Subject Expert Committee meeting materials and attending SEC meetings for clinical trials and marketing approvals Your secondary responsibilities will involve: - Reviewing Medical Review of ICSRs, Aggregate reports, Signal reports, and Risk Management plans - Reviewing clinical and non-clinical overviews and summaries of CTD - Reviewing medical rationale for CT waiver applications - Evaluating new products for development - Developing, reviewing, and approving marketing requests of product evaluations, comparative safety, and efficacy training material - Mentoring/training team members to gain required skills to enable on-time deliverables.,

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Hetero

Pharmaceuticals

Hyderabad

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ASSISTANT GENERAL MANAGER/DEPUTY GENERAL MANAGER-MEDICAL AFFAIRS