Assistant General Manager/Deputy General Manager - Medical Affairs

Roles & Responsibilities

• Perform medical monitoring of in-house clinical trials and oversee CRO medical monitoring for outsourced projects
• Review and approve clinical documents, including protocols, investigator's brochures, case record forms, product rationale, prescribing information, and drug interactions
• Organize Subject Expert Committee meeting materials and attend SEC meetings for clinical trials and marketing approvals
• Conduct medical reviews of ICSRs, aggregate reports, signal reports, and risk management plans
• Review clinical and non-clinical overviews and summaries of the CTD
• Review medical rationale for CT waiver applications
• Evaluate new products for development and contribute to the decision-making process
• Develop, review, and approve marketing requests for product evaluations, comparative safety, and efficacy training material
• Mentor and train team members to enhance their skills for timely deliverables
• Provide guidance and leadership to ensure successful completion of projects

Qualification

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

Experience

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

Vacancies

• 1

Skills

• Medical monitoring, clinical trials, CRO management
• Strong understanding of protocol development and risk management plans
• Clinical document review and development
• Experience with ICSR, aggregate reports, signal reports, CTD summaries
• Strong mentorship, training, and leadership skills
• Excellent communication and organizational skills

About The Company

Hetero Healthcare Limited is a leading pharmaceutical company committed to providing high-quality, innovative medicines to the global healthcare market. The company is at the forefront of clinical research and development, working on innovative therapies to address unmet medical needs. Hetero Healthcare offers a dynamic work environment, with opportunities for growth and advancement in various medical and healthcare disciplines.