PRIMARY FUNCTION/OBJECTIVE
To lead Team members and activities of all Non-Interventional Studies (NIS) including regulatory PMSS, Access Program(PAA/PTA), Multi-country NIS(MCNIS), Affiliate-Sponsored Studies, and IIS in accordance with relevant SOPs and regulatory requirement.

• Manage medical research operations and represent all Non-Interventional Studies (NIS) including
regulatory PMSS, Access Program(PAA/PTA), Multi-country NIS(MCNIS), Affiliate-Sponsored Studies, and IIS operations on cross-functional projects teams, internally/externally.
• Responsible and accountable for planning coordination, overseeing, and conducting all NonInterventional Studies (NIS) including regulatory PMSS, Access Program(PAA/PTA), Multi-country NIS(MCNIS), Affiliate-Sponsored Studies, and IIS Ensure all Non-Interventional Studies (NIS) activities are performed according to corporate, ethical, and legal requirements.
• Line management and mentoring of medical research & operation team.
• Manage workload, plans and resource needs of medical research & operation team.
• Proactive planning process experts for study budget planning, LRP, study budget tracking and management
• Conduct quality and compliance monitoring in medical research and operation
• Operational oversight and execution of medical initiatives/deliverables, monitors status of deliverables and addresses deviation proactively.
• Lead and provide guidance, oversight, review as well as come up with the best option regarding newly conducted types of studies such as Post Trial Access program, IP supply IIS, Collaborative research, etc. including L-AGN studies, assets.

[Regulatory PMSS]
• Plan and prepare study concept/ protocol in advance to submit them with NDA dossiers. (2-3 years advance than product launch)
• Provide regulatory requirements, estimated budget, realistic target subject number to crossfunctional team when New asset/New indication is discussed.
• Estimate and predict if PMSS is completed within given study period and target subject enrollment considering NDA approval/ product launch date.
• Develop a strategy how to submit re-examination period for New indication.
• Lead and provide guidance, oversight, review regarding preparing reference documents to be submitted to MFDS, specifically target subject suggestion when submitting at first, target subject number adjustment when half of study period is passed, plan for enrollment completion within study period when requested.

Qualifications

PREFERRED QUALIFICATIONS
• Bachelor’s degree and preferably in pharmacy, nursing, or relevant scientific discipline
• Significant clinical research experience (more than 7 years-preferred)
• Excellent knowledge of clinical research practices, local regulations, and ICH guidelines
• Advanced skills in Project Management, particularly, regarding management of schedule, budget, communication, resources, and quality
• Experience in people management and leadership, including performance appraisal.
• Good interpersonal and effective communication skills and experience developing relationships across functions.
• Experience in resource and financial management
• Read, write and speak fluently in English, excellent verbal and written communication skills.

Additional Information

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