北京招聘

Key Responsibilities

1.       As a member of Study Team, following the timeline to prepare high quality clinical protocols, clinical study reports, narratives, literature review, abstracts, posters and slide sets supporting clinical study (incl. IIT) conduction, regulatory submissions and meetings with HAs or MHs as needed.

2.       Participate in planning of analysis, investigators meetings and data presentation to be used in study report. May act as documentation consultant in clinical trial teams to ensure compliance of documentation to internal company standards and external regulatory guidelines.

3.       Perform quality control (QC) checking/proof reading of the documents.

4.       Assist in outsourcing to external medical writers. Maintains records for all assigned projects including archiving.

5.    Compliance with NJ Legend standards, policies and applicable regulations.

Required Knowledge, Skills and Abilities

1.       Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.

2.       Good therapeutic and protocol knowledge as provided in company training.

3.       Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer.

4.       Good written and verbal communication skills including good command of English language.

5.       Good organizational and problem-solving skills.

6.       Effective time management skills.

7.       Ability to establish and maintain effective working relationships with stakeholders.

Minimum Required Education and Experience

1.       Bachelor's degree in a health care or other scientific discipline or educational equivalent.

Physical Requirements

1.       Extensive use of telephone and face-to-face communication requiring accurate perception of speech.

2.       Extensive use of keyboard requiring repetitive motion of fingers.

3.       Regular sitting for extended periods of time.

4.       Locates in tier one/two cities in China and requires frequent travel to sites.

传奇生物（NASDAQ: LEGN）是一家处于临床阶段的全球生物制药公司，专注于肿瘤和其他领域的新型细胞疗法的开发。目前，公司在中国、美国、欧洲拥有800多名员工。运用创新的技术手段、全球研发模式、生产策略和专业知识，公司具备强大的潜力为患者开发和制造一流的细胞疗法。传奇生物通过战略合作开发和商业化旗下主导产品西达基奥仑赛（cilta-cel），这是一种靶向BCMA的CAR-T细胞疗法用于治疗多发性***瘤患者，该药物目前正处于注册临床试验阶段。