北京招聘

The Archivist supports the regulatory submission process by managing archiving of submission documents both in paper and electronic format, correspondence and communications, data management, and process evaluation and control. All in compliance with applicable regulations, standards, and internal policies and procedures. This position responsible for maintaing the regulatory archive.
Essential Duties & Responsibilities (Primary):
?Archiving
?Manage and maintain submissions and correspondence in the regulatory archive system
?Coordinate exchange of records using document sharing platforms
?Generate metrics, reports, and dashboards
?Reconcile data
?Archives/retrieves regulatory documents (both paper and electronic) as necessary.
?Ensure that all documents are maintained in a Central Records facility and are organized and identified so that they can be easily retrieved.
?Coordinate regular transfer of the department's inactive records to and from offsite storage.
?Ensure that records are maintained in accordance with current procedures and Records Retention Schedules.
?Assist in the development and maintenance of SOPs and Work Instructions as related to archiving processes.
?Assist in providing solutions to a variety of routine process and technology issues.
?Assist in archiving projects as needed
职位要求：
Core Competencies, Knowledge and Skill Requirements:
?Working knowledge of Microsoft Office and Adobe systems.
?Ensures that all documents required by regulations or SOPs are maintained in a Central Records facility and are organized and identified so that they can be easily retrieved.
?Has a working understanding of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authority.
?Regulatory Operations Filing Requirement (NDA, BLA, IND)
?General Drug Registration Process and Post-approval maintenance requirements
?Drug Registration Types, Submission Types
?eCTD
?Library science and records management skills preferred.
?Works under general supervision and follows established procedures.
?Experience with Veeva Systems
Communication & Interpersonal Skills:
?Strong attention to detail
?Excellent organizational and multi-tasking skills.
?Excellent written, verbal, and interpersonal communication skills.
?Able to work in a fast-paced environment
?Able to effectively manage under pressure
?Ability to prioritize and handle multiple projects simultaneously.requirements
Education: BA/BS Degree in library science, life sciences, computer science or related fields.
Experience: Regulatory Operations, Regulatory Information Management experience preferred but not required
Regulatory operations experience preferably within a healthcare environment with experience and knowledge in formatting, publishing and archiving of INDs, NDAs, amendments and supplements (manufacturing, nonclinical, clinical). Knowledge of NMPA, FDA and ICH regulations and guidance as it pertains to format, submission structure, archiving and records retention. Familiar with regulatory requirements for other regions desirable. The candidate should be detail-oriented, and able to work under supervision in a team environment.
Travel, Physical DEmands and work environment (AS APPROPRIATE FOR THE POSITION)
Regularly required to operate standard office equipment (personal computer, photocopy machine, etc.)

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