Medical Affairs Manager

[Purpose Statement]

Lead the Medical Affairs function in Korea, supporting product and therapy strategies with clinical and scientific expertise. Partner with global/regional teams and cross-functional stakeholders to ensure high-quality evidence generation, clinical education and strict compliance with regulatory and quality standards. Own team operations, capability building, and resource planning to achieve business and patient-centric objectives.

[Key Responsibilities]

1. 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

2. 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

3. 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)
  

4. 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

5. External Engagement & KOL partnership

• Strengthening KOL and institutional networks
• Plan and lead advisory boards, symposia, and scientific engagement activities

[Required 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

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