Website Humphries Pharmaceutical Consulting Co.

Job Description:

Humphries Pharmaceutical Consulting Co., a subsidiary of one of the largest Chinese publicly traded contract research organizations (CRO), with a US office located in Bethesda, Maryland, is looking for a full-time – Project Assistant.  This is an ideal opportunity for young professional who is considering career change.

Tasks include:

  • Facilitate new drugs, biologics through the investigational studies and approval process, including initial preclinical, CMC and clinical support, pre-submission assistance (e.g. INTERACT and pre-IND meetings), application submission and maintenance (e.g. IND, IND Amendment, EOP meetings), applicability of accelerated approval pathways.
  • Work as an independent self-starter. Able to manage multiple tasks, willing to actively seek information necessary to complete assignments.
  • Collaborate with both internal and external teams to ensure the regulatory tasks are delivered in timely manner.
  • Communicate clearly w/ clients and partners (personal, phone, email) to coordinate and assist the progress of the regulatory tasks.
  • Drafting technical documents for regulatory submissions. Provide regulatory review and ensure submissions comply with applicable regulations and guidance documents.
  • Coordinating meetings and taking down minutes.

Requirements:

  • Bilingual (Chinese and English)
  • Doctoral degree in biomedical science, pharmaceutical sciences, Chemistry is preferred
  • With biological, pharmaceutical or medical background.
  • Possess interpersonal skills to work with external and internal staffs. Effective in oral and written communications.
  • Skilled in Microsoft Office computer applications, specifically Microsoft Word, Excel and PowerPoint

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