We are seeking a dynamic and collaborative project manager to support our company s research and development department for unmet medical needs and our mission of affordable innovation. S/he will be responsible for facilitating early-stage product development from discovery through IND and beyond, pushing the boundaries of what is possible in a highly competitive industry and collaborating with our Taiwan and China sites.
- Build pipelines, timelines and budgets for R&D projects from initiation to IND approval.
- Continue monitoring pipelines, timelines and budgets for clinical stage projects to marketing approval.
- Schedule meetings, record meeting minutes and ensure timely execution of action items.
- Coordinating resources, materials, and priorities among multiple international sites to organize and carry out tasks for each managed project in the most efficient manner
- Pipeline analytics and metrics reporting.
- Support clinical stage projects as point of contact for production outsourced to GMP contract manufacturing organizations (CMO).
- Support the regulatory affairs division for clinical stage projects with new eCTD submissions, annual reports, safety reports, and end of phase reports.
- 2+ years of experience in biotech industry with a Bachelor s degree in related field or 1+ years of experience with Master s degree.
- Strong knowledge of Microsoft Excel, Powerpoint and other related tools.
- Experience with antibody research preferred.
- Knowledge of US, EU and ICH regulatory requirements is a plus.
- Quick learner who can thrive under pressure in a fast-paced environment.
- Outstanding writing and verbal communication, team and regulatory leadership, negotiation and multitasking skills, goal and detail-orientated execution in a teamwork environment.
- Strong business acumen, strategic thinking and interpersonal effectiveness.
- Fluency in English required, and proficiency in Chinese highly desirable.
Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task