Job title: Medical Operations & Engagement Manager
Division / Business Unit: South Korea, Medical, Vaccines
Location: Seoul, South Korea
About the job
Our Team:
The Medical Vaccines Team at Sanofi is a high-performing team of medical leaders who are a trusted source of scientific and medical information and shared insights; effective and innovative strategic partners to our internal and external stakeholders; and dedicated to public health. We represent diverse experiences and backgrounds which strengthens our team and mirrors the healthcare communities we engage.
Main Responsibilities:
The Medical Operations & Engagement Manager role owns a medical operations and engagement function across franchises to strengthen operational excellence across vaccine franchises by managing critical process areas such as Post-Marketing Surveillance (PMS) and other study projects, field medical excellence and stakeholder engagement. This role will serve as a key enabler for Vaccines Medical, realizing the full potential for success as a Medical Affairs Team and ensuring compliance, medical excellence and operational continuity. The role impacts on important areas in medical (study) operational, field medical portfolio framework & discipline and also launch excellence aspects.
The main responsibilities of the role include:
Study Management Support
•Serve as the primary in-country contact for all Post-Marketing Surveillance (PMS) programs, with key connectivity and collaboration through to Platform Medical Study Leaders Group
•Monitor PMS study timelines and proactively flag risks of the timely progress
•Monitor the PMS study tracker covering all active and upcoming studies, deadlines and regulatory submission milestones
•Liaise with Regulatory Affairs to align PMS deliverables with license renewal and variation timelines
•Monitor all PMS activities are conducted in compliance with MFDS guidelines, ICH GCP, and Sanofi SOPs
•In support of study programs more broadly, coordinate with global/regional study teams, CROs, and local investigators to ensure timely study initiation, enrolment, data collection and reporting as required
Field Medical Excellence & Capabilities
•Design and/or implement field medical excellence frameworks with a formalized field medical operating model
•Track and report on field medical activity metrics, identifying gaps and recommending solutions
•Support and collaborate with medical personnel in field engagements
External Stakeholder Engagement Support
•Leadership in and synergy with the current hybrid (office/field) responsibility of Medical Affairs team members, ensuring execution and quality of stakeholder mapping, prioritization & engagement as well as planning and metrics
•Manage the medical congress calendar for South Korea, coordinating Sanofi Vaccines presence and medical engagement activities
•Support medical education initiatives and scientific exchange programs with external stakeholders to enhance scientific engagement and disease awareness
Medical Operations & Governance
•Serve as GxP ambassador
•Maintain the medical activities calendar and ensure cross-functional visibility of key medical milestones
•Coordinate with the MCO (Multi-Country Organization) team to ensure Korea's medical activities are aligned with regional priorities
Respiratory Portfolio Strategy Coordination:
•Serve as the operational coordinator for integrated respiratory portfolio initiatives across vaccine franchises in South Korea, ensuring alignment across current and future portfolio priorities
•Support respiratory and infectious disease medical initiatives, including the development of scientific content for congresses, educational programs, and field medical activities
•Coordinate with global, regional, and local medical teams to ensure consistent and locally relevant scientific communications and medical strategies
•Coordinate cross-functional alignment meetings between Medical, Commercial, Market Access, and Regulatory teams to support portfolio priorities and strategic objectives
•Track and report on the implementation of key medical and portfolio initiatives at the country level, providing regular updates to the Country Medical Head and regional stakeholders
About you
Education/Experience/Certification:
•Bachelor's degree minimum in Life Sciences, Pharmacy, Nursing or a related health sciences field (required)
•Master's degree or PharmD in a relevant discipline (preferred)
•Medical degree (MD) or PhD in a biomedical field (advantageous)
•Minimum 3 years of experience in the pharmaceutical/biotech industry in roles spanning Field Medical, Regulatory Affairs, Clinical Operations or related functions
•Demonstrated experience in regulatory PMS study management in South Korea, with working knowledge of MFDS requirements
•Experience in project management of complex, multi-stakeholder programs
•Prior exposure to vaccines, respiratory or infectious disease therapeutic areas (strongly preferred)
•Experience working in a matrix organization with global/regional teams
•Working knowledge of MFDS PMS regulations and Korean pharmaceutical regulations
•Familiarity with ICH-GCP guidelines and pharmacovigilance requirements
•Understanding of KRPIA code of conduct and medical affairs compliance standards
