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Assistant General Manager/Deputy General Manager-Medical Affairs

5 - 9 years

0 Lacs

hyderabad telangana

Posted:1 week ago| Platform: Shine logo

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Skills Required

medical monitoring clinical trials protocol development product evaluations mentoring training cro oversight clinical documents development investigators brochure review subject expert committee meeting organization icsrs review aggregate reports review signal reports review risk management plans review ctd summaries review new products evaluation marketing requests review safety efficacy training

Work Mode

On-site

Job Type

Full Time

Job Description

As a Medical Monitor, you will be responsible for overseeing the medical aspects of in-house clinical trials and managing the CRO's medical monitoring for outsourced projects. Your duties will include developing and reviewing various clinical documents such as protocols, investigator's brochures, case record forms, product rationales, prescribing information, and drug interactions. You will also be tasked with organizing materials for Subject Expert Committee (SEC) meetings and actively participating in these meetings to support clinical trials and marketing approvals. In addition to the primary responsibilities, you will be involved in the medical review of Individual Case Safety Reports (ICSRs), aggregate reports, signal reports, and Risk Management plans. You will also review clinical and non-clinical overviews and summaries of Common Technical Documents (CTD) and assess the medical rationale for Clinical Trial (CT) waiver applications. Furthermore, you will be expected to evaluate new products for development, as well as develop, review, and approve marketing requests related to product evaluations, comparative safety, and efficacy training materials. Additionally, you will play a key role in mentoring and training team members to enhance their skills and ensure timely project deliverables.,

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