General Manager/Deputy General Manager

Roles & Responsibilities
• Medical monitoring of in-house clinical trials and overseeing CRO medical monitoring of outsourced projects.
• Development and review of clinical documents including protocols, investigator’s brochures, case record forms, product rationale, prescribing information, drug interactions, etc.
• Organize Subject Expert Committee (SEC) meeting materials and attend SEC meetings for clinical trials and marketing approvals.
• Medical review of ICSRs, Aggregate reports, Signal reports, and Risk Management plans.
• Review clinical and non-clinical overviews and summaries of CTD (Common Technical Document).
• Review medical rationale for CT waiver applications.
• Evaluation of new products for development.
• Development, review, and approval of marketing requests for product evaluations, comparative safety, and efficacy training material.
• Mentor and train team members to ensure timely deliverables.

Qualification
• Medical degree (MD or equivalent) with specialization in a relevant field.

Experience
• 5 - 9 years of experience in medical monitoring of clinical trials and oversight of CRO medical monitoring.
• Strong understanding of clinical document development and review processes.
• Knowledge of regulatory requirements related to clinical trials and marketing approvals.

Vacancies
• 1 Assistant

Skills
• Medical monitoring, clinical trials, and CRO experience.
• Expertise in protocol development, risk management plans, and clinical document review.
• Experience in ICSR, aggregate reports, signal reports, and CTD summaries.
• Ability to evaluate new products and review marketing requests.
• Strong mentoring and training skills.
• Excellent communication and organizational skills.

About the Company
Hetero Healthcare Limited is a leading pharmaceutical company committed to the development and production of a wide range of high-quality medicines. With a strong focus on medical and healthcare innovations, Hetero is dedicated to providing advanced healthcare solutions and improving patient outcomes. The company operates globally and is known for its expertise in medical research, regulatory compliance, and product development.