
Posted 10 days ago
Senior Project Manager
ParexelSenior Project Manager - PC
Requirements
7+ years in Pharma, Biotech, or CRO, Regulatory Compliance (GMP) experience, US NDA/EU MAA experience preferred, Native Korean proficiency, Proficient English
Skills
Project ManagementGMP
About the role
Responsibilities
- Lead cross-functional teams to deliver high-quality, patient-focused clinical trials and regulatory affairs projects.
- Manage project requirements, timelines, budgets, and resource planning for domestic or international core services.
- Act as the primary sponsor liaison, ensuring effective communication between the Parexel project team and the client.
- Oversee project implementation, milestone tracking, and forecasting to ensure compliance with contract and quality standards.
- Ensure all project activities adhere to local regulations, SOPs, and quality guidelines.
- Produce key project progress reports and manage financial and contract management tasks.
Requirements
- Minimum of 7 years of experience in Pharma, Biotech, or a Contract Research Organization (CRO).
- Proven experience in Project Management specifically related to Regulatory Affairs (RA) and Business Support.
- Native Korean proficiency and professional English proficiency for global team collaboration.
- Experience with Regulatory Compliance (GMP) is required.
Preferred Qualifications
- Experience with US NDA (New Drug Application) or EU MAA (Marketing Authorisation Application) processes.
Benefits
- Flexible working arrangements, including hybrid work options.
- Supportive and inclusive work environment with a focus on relationship building.
- Opportunities for significant career progression within the global Project Leadership group.
- Exposure to a diverse range of therapeutic areas and client types, from small biotech to large pharmaceutical companies.
About the Company
Parexel is a global leader in clinical research, dedicated to helping the world's experts take on critical diseases. We empower our teams to bring life-changing treatments to market faster through patient-centric clinical trials and expert regulatory guidance.
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Parexel · Seoul
