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
- Job Types: Full-time
- Contact: Jin Chen (jinchen@humphriespcc.com)