• Project Documentation Specialist

    Job Location(s) CN-Shanghai
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  • Job Overview

    1. Review of regulatory application form against the SOW to ensure accuracy and compliance
    2. Coordinate with other departments for the completeness of documentations / applications
    3. Obtain relevant internal authorization for the documents as applicable
    4. Close collaboration with the Global Study Manager (GSM) or the Regional Study Coordinator (RSC) for all regulatory documentations aspects of the protocol.
    5. Maintain knowledge of current regulatory documentation requirements and guidelines, and communicate with the Global Project Management team of any changes
    6. Maintain all records related to the regulatory documentations / applications for the ease of retrieval in case of inspection
    7. Responsible for implementing compliance monitoring of regulatory documentation practices and taking corrective and preventive actions when needed
    8. Ensure a detailed knowledge of the SOW specifications and a good understanding of how the SOW specifications impact every operational aspect of the clinical trial, in particular those relevant to the regulatory documentations / applications
    9. Monitor, and track the completion of all regulatory documentations / applications support requests assigned. Keep the GSM or RSC informed of the progress and follow-up with the GSM or RSC if it is pending action by the client.
    10. Participate in functional meetings (eg. CLFs) and provide input, keeping processes up to date
    11. Ensure compliance with departmental guidelines and company standards.
    12. Comply with CCLS Global Project Management strategy
    13. Support a culture of continuous improvement, quality and productivity
    14. Other duties as assigned


    Minimum Required:

    • High School Diploma
    • Ability to use computer and office software applications (e.g. Microsoft Word, Excel, and Outlook)
    • Interpersonal skills
    • Strong in English, and Chinese (Mandarin)
    • Strong administrative and organizational skills



    • (2) year vocational or Associate’s Degree in Life Sciences or equivalent


    Minimum Required:

    • Preferred 1 year experience within Covance or 2 years’ experience in applicable field
    • Demonstrated ability to plan and prioritize.
    • Demonstrated communication and organizational skills.
    • Demonstrated attention to detail.
    • Demonstrated documentation skill.
    • Proven ability to excel in a fast paced environment
    • Proven teamwork
    • Demonstrated ability to liaise with internal departments


    2 years administrative experience, preferable in pharmaceutical industry (Education may be substituted for experience)


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