Medical Affairs Manager

Description

• Medical Affairs Strategy & Operations
• Represent Korea Medical Affairs and collaborate with global/regional and cross-functional partners (Clinical, RA/QA, Marketing, FIN, Supply chain etc.)
• Drive policy/process development and operational excellence
• Build and manage annual medical plans, budgets, and resources
• Lead people development, coaching, performance management, and staffing
• Clinical Evidence Generation & Research Management
• Provide medical review and ensure quality/compliance for local/global clinical studies and pre-market studies
• Review study documents (Protocol, CRF, ICF, etc.) and ensure compliance with regulations, BSC SOPs, and GCP
• Lead communications with investigators/sites to monitor study progress and resolve issues
• Secure and manage essential resources (investigators, institutions, documentation, budget, vendor/site contracts, material resources) required for participation in pre‑market or global clinical studies; proactively identify timelines/risks and implement mitigation
• HCP Scientific Program & Internal Education/Consultation
• Provide therapeutic/product scientific consultation based on current evidence
• Plan and deliver HCP engagement programs and up-to-date safety/clinical use information
• Provide internal medical training (product knowledge, clinical data updates)
• Medical Compliance & Quality
• Ensure compliance with regulations, BSC Quality Policy, and SOPs across all medical activities
• Lead audit responses and CAPA activities
• Own medical review for ethics and promotional/advertising materials
• External Engagement & KOL partnership
• Strengthening KOL and institutional networks
• Plan and lead advisory boards, symposia, and scientific engagement activities

Qualifications

• Bachelor's degree in life sciences or related field
• Fluent in English, with the ability to communicate effectively across global and regional stakeholders
• 15–20 years of experience in Medical Affairs, Clinical Research, or related areas, including a minimum of 3 years of people and team management experience
• Strong cross-functional communication and stakeholder management
• Demonstrated people leadership

[Preferred Qualifications]

• Advanced degree (Master, PhD) in Medicine (MD, MSc), Biomedical Sciences (MSc/PhD in Biomedical Science), Life Sciences (MSc/PhD in Physiology), Public Health / Epidemiology (MPH, MSc in Epidemiology)
• Experience in global clinical research, including Korea’s participation in pre-approval trials
• Deep understanding of MedTech/pharma regulations, GCP, clinical trial processes, and data integrity