美国招聘RA Director或senior manager,homework

职位解析：

1)汇报给国内的CMO

2)和美国当地的一个RA顾问合作

3)当地行政事务汇报给美国CBO

4)在家办公 

5)硕士5年以上或博士3年以上RA经验，特别是临床策略方面

6)公司已完成过亿元的A轮融资

MAIN REPONSIBILITIES:

1. Ensure all clinical trials are executed in compliance with domestic and international GCP guidelines/regulations and applicable SOPs.

2. Oversee coordination and planning of interactions, communications and submissions to regulatory authorities and ethics committee, as appropriate.

3. Provide oversight of CRO and consultant activities performed for company clinical programs as related to regulatory submission activities, including management of submission strategy and timelines, as well as identification and resolution of any performance issues.

4. Participate in development and writing of INDs, protocols, Investigator Brochure(s) and other relevant clinical trial documents Direct the preparation and submission of regulatory agency applications, reports and correspondence.

5. Oversee documentation to ensure compliance with domestic and international regulations and standards.

6. Identify requirements for submissions ensuring accuracy, consistency and completeness while adhering to regulatory standards, SOPs and work guidelines as required.

7. Develop, manage and maintain regulatory affairs SOPs; implement regulatory affairs policies and procedures to ensure regulatory compliance is maintained.

8. Participate in evaluation of system for internal file storage and controlled document management.

9. Participate in the development of departmental timelines and budgets, as well as review and approval of relevant vendor invoices.

10. Functional representative on project teams, study teams, including multi-disciplinary interactions.

QUALIFICATIONS:

11. Proven organizational skills with the ability to prioritize and work well in an environment with competing demands.

12. Experience in and knowledge of industry regulations and requirements pertaining to clinical trials.

13. Strong, interpersonal, motivation and negotiation skills with an ability to communicate effectively at all levels.

14. Knowledge of ICH, GCP, GMP, Data Privacy and other applicable regulations and requirements in the pharmaceutical industry

15. Strong influence and relationship building ability.

16. Ability to plan, organize and monitor activities according to priorities, established schedules and deadlines.

17. Ability to adapt to small-company hands-on culture.

18. Team management skills, good coordination, and communication skills.

19. Teamwork spirit and sense of work responsibility.

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