FDA临床研究申报公司招一个Project assistant

Project Assistant

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 in regulatory affairs.
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)
•        Bachelor’s degree or higher in biomedical science, pharmaceutical sciences, Chemistry
•        Working experience in biological, pharmaceutical or clinical trial is desired
•        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 or internship
•        Potential for H1B visa sponsorship
•        Please send resume to hr-linkedin@humphriespcc.com