Project Manager

hengenix Biotech in Fremont, CA

  • Type: Full Time
position filled

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.


Key Responsibilities:

  • 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.


Requirements

  • 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

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